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FDA PeekMed Radiology Software 510(k) Notification

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Detected March 23rd, 2026
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Summary

The FDA has published a 510(k) premarket notification for PeekMed web radiology software. This notification indicates that the software has met the requirements for market entry, allowing it to be used by healthcare providers.

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What changed

The U.S. Food and Drug Administration (FDA) has posted a 510(k) premarket notification for PeekMed web radiology software, identified by K252856. This filing signifies that the FDA has reviewed the software and determined it to be substantially equivalent to legally marketed predicate devices, clearing it for commercial distribution in the United States.

This notification is primarily informational for compliance officers and legal professionals. It confirms that PeekMed's radiology software has successfully navigated the FDA's premarket notification process. While this is not a new rule or guidance, it is relevant for understanding the regulatory landscape of AI-enabled medical devices and ensuring that any similar software used or developed by an organization complies with FDA requirements.

Source document (simplified)

510(k) Premarket Notification

- Databases

| | | | | | 510(k) | \| | DeNovo | \| | Registration & Listing | \| | Adverse Events | \| | Recalls | \| | PMA | \| | HDE | \| | Classification | \| | Standards |

| CFR Title 21 | \| | Radiation-Emitting Products | \| | X-Ray Assembler | \| | Medsun Reports | \| | CLIA | \| | TPLC | | | 510(k) | | | DeNovo | | | Registration & Listing | | | Adverse Events | | | Recalls | | | PMA | | | HDE | | | Classification | | | Standards | CFR Title 21 | | | Radiation-Emitting Products | | | X-Ray Assembler | | | Medsun Reports | | | CLIA | | | TPLC | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510(k) | | | DeNovo | | | Registration & Listing | | | Adverse Events | | | Recalls | | | PMA | | | HDE | | | Classification | | | Standards | | | | | | | | | | | | | | | | |
| CFR Title 21 | | | Radiation-Emitting Products | | | X-Ray Assembler | | | Medsun Reports | | | CLIA | | | TPLC | | | | | | | | | | | | | | | | | | | | | | |

| | \| New Search \| Back To Search Results \| | New Search | Back To Search Results | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| New Search | Back To Search Results | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| \| \| Device Classification Name \| Automated Radiological Image Processing Software \| \| \| \|
\| --- \| --- \| \| \| \|
\| 510(k) Number \| K252856 \| \| \| \|
\| Device Name \| PeekMed web \| \| \| \|
\| Applicant \| \\| Peek Health, S.A. \\|
\\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \\|
\\| Braga, 

PT

4719-005 \\| \| Peek Health, S.A. \| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| Braga, 

PT

4719-005 \|
\| Peek Health, S.A. \| \| \| \| \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| \| \| \| \|
\| Braga, 

PT

4719-005 \| \| \| \| \|
\| Applicant Contact \| Sara Silva \| \| \| \|
\| Correspondent \| \\| Peek Health, S.A. \\|
\\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \\|
\\| Braga, 

PT

4719-005 \\| \| Peek Health, S.A. \| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| Braga, 

PT

4719-005 \|
\| Peek Health, S.A. \| \| \| \| \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| \| \| \| \|
\| Braga, 

PT

4719-005 \| \| \| \| \|
\| Correspondent Contact \| Sara Silva \| \| \| \|
\| Regulation Number \| 892.2050 \| \| \| \|
\| Classification Product Code \| \\| QIH \\| \| QIH \| \| \|
\| QIH \| \| \| \| \|
\| Subsequent Product Code \| \\| LLZ \\| \| LLZ \| \| \|
\| LLZ \| \| \| \| \|
\| Date Received \| 09/09/2025 \| \| \| \|
\| Decision Date \| 12/22/2025 \| \| \| \|
\| Decision \| Substantially Equivalent 

(SESE) \\\|  \\\|  \\\|  \\\|

\| Regulation Medical Specialty \| Radiology \| \| \| \|
\| 510k Review Panel \| Radiology \| \| \| \|
\| Summary \| Summary \| \| \| \|
\| Type \| Traditional \| \| \| \|
\| Reviewed by Third Party \| No \| \| \| \|
\| Combination Product \| No \| \| \| \|
\| Predetermined Change
Control Plan Authorized \| No \| \| \| \| \| Device Classification Name \| Automated Radiological Image Processing Software \| 510(k) Number \| K252856 \| Device Name \| PeekMed web \| Applicant \| \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| \| Peek Health, S.A. \| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| Braga, 

PT

4719-005 \| Applicant Contact \| Sara Silva \| Correspondent \| \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| \| Peek Health, S.A. \| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| Braga, 

PT

4719-005 \| Correspondent Contact \| Sara Silva \| Regulation Number \| 892.2050 \| Classification Product Code \| \| QIH \| \| QIH \| Subsequent Product Code \| \| LLZ \| \| LLZ \| Date Received \| 09/09/2025 \| Decision Date \| 12/22/2025 \| Decision \| Substantially Equivalent 

(SESE) \\| Regulation Medical Specialty \\| Radiology \\| 510k Review Panel \\| Radiology \\| Summary \\| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252856.pdf) \\| Type \\| Traditional \\| Reviewed by Third Party \\| No \\| Combination Product \\| No \\| Predetermined Change

Control Plan Authorized \| No \|
\| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \|
\| Device Classification Name \| Automated Radiological Image Processing Software \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| 510(k) Number \| K252856 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Device Name \| PeekMed web \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Applicant \| \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| \| Peek Health, S.A. \| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| Braga, 

PT

4719-005 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Peek Health, S.A. \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Braga, 

PT

4719-005 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Applicant Contact \| Sara Silva \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Correspondent \| \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| \| Peek Health, S.A. \| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| Braga, 

PT

4719-005 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Peek Health, S.A. \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Braga, 

PT

4719-005 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Correspondent Contact \| Sara Silva \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Regulation Number \| 892.2050 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Classification Product Code \| \| QIH \| \| QIH \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| QIH \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Subsequent Product Code \| \| LLZ \| \| LLZ \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| LLZ \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Date Received \| 09/09/2025 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Decision Date \| 12/22/2025 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Decision \| Substantially Equivalent 

(SESE) \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|  \\|

\| Regulation Medical Specialty \| Radiology \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| 510k Review Panel \| Radiology \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Summary \| Summary \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Type \| Traditional \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Reviewed by Third Party \| No \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Combination Product \| No \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Predetermined Change
Control Plan Authorized \| No \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| | \| Device Classification Name \| Automated Radiological Image Processing Software \| \| \| \|
\| --- \| --- \| \| \| \|
\| 510(k) Number \| K252856 \| \| \| \|
\| Device Name \| PeekMed web \| \| \| \|
\| Applicant \| \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| \| Peek Health, S.A. \| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| Braga, 

PT

4719-005 \|
\| Peek Health, S.A. \| \| \| \| \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| \| \| \| \|
\| Braga, 

PT

4719-005 \| \| \| \| \|
\| Applicant Contact \| Sara Silva \| \| \| \|
\| Correspondent \| \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| \| Peek Health, S.A. \| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| Braga, 

PT

4719-005 \|
\| Peek Health, S.A. \| \| \| \| \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| \| \| \| \|
\| Braga, 

PT

4719-005 \| \| \| \| \|
\| Correspondent Contact \| Sara Silva \| \| \| \|
\| Regulation Number \| 892.2050 \| \| \| \|
\| Classification Product Code \| \| QIH \| \| QIH \| \| \|
\| QIH \| \| \| \| \|
\| Subsequent Product Code \| \| LLZ \| \| LLZ \| \| \|
\| LLZ \| \| \| \| \|
\| Date Received \| 09/09/2025 \| \| \| \|
\| Decision Date \| 12/22/2025 \| \| \| \|
\| Decision \| Substantially Equivalent 

(SESE) \\|  \\|  \\|  \\|

\| Regulation Medical Specialty \| Radiology \| \| \| \|
\| 510k Review Panel \| Radiology \| \| \| \|
\| Summary \| Summary \| \| \| \|
\| Type \| Traditional \| \| \| \|
\| Reviewed by Third Party \| No \| \| \| \|
\| Combination Product \| No \| \| \| \|
\| Predetermined Change
Control Plan Authorized \| No \| \| \| \| | Device Classification Name | Automated Radiological Image Processing Software | 510(k) Number | K252856 | Device Name | PeekMed web | Applicant | \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 | Applicant Contact | Sara Silva | Correspondent | \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 | Correspondent Contact | Sara Silva | Regulation Number | 892.2050 | Classification Product Code | \| QIH \| | QIH | Subsequent Product Code | \| LLZ \| | LLZ | Date Received | 09/09/2025 | Decision Date | 12/22/2025 | Decision | Substantially Equivalent 

(SESE) \| Regulation Medical Specialty \| Radiology \| 510k Review Panel \| Radiology \| Summary \| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252856.pdf) \| Type \| Traditional \| Reviewed by Third Party \| No \| Combination Product \| No \| Predetermined Change

Control Plan Authorized | No |
| \| Device Classification Name \| Automated Radiological Image Processing Software \| \| \| \|
\| --- \| --- \| \| \| \|
\| 510(k) Number \| K252856 \| \| \| \|
\| Device Name \| PeekMed web \| \| \| \|
\| Applicant \| \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| \| Peek Health, S.A. \| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| Braga, 

PT

4719-005 \|
\| Peek Health, S.A. \| \| \| \| \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| \| \| \| \|
\| Braga, 

PT

4719-005 \| \| \| \| \|
\| Applicant Contact \| Sara Silva \| \| \| \|
\| Correspondent \| \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| \| Peek Health, S.A. \| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| Braga, 

PT

4719-005 \|
\| Peek Health, S.A. \| \| \| \| \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| \| \| \| \|
\| Braga, 

PT

4719-005 \| \| \| \| \|
\| Correspondent Contact \| Sara Silva \| \| \| \|
\| Regulation Number \| 892.2050 \| \| \| \|
\| Classification Product Code \| \| QIH \| \| QIH \| \| \|
\| QIH \| \| \| \| \|
\| Subsequent Product Code \| \| LLZ \| \| LLZ \| \| \|
\| LLZ \| \| \| \| \|
\| Date Received \| 09/09/2025 \| \| \| \|
\| Decision Date \| 12/22/2025 \| \| \| \|
\| Decision \| Substantially Equivalent 

(SESE) \\|  \\|  \\|  \\|

\| Regulation Medical Specialty \| Radiology \| \| \| \|
\| 510k Review Panel \| Radiology \| \| \| \|
\| Summary \| Summary \| \| \| \|
\| Type \| Traditional \| \| \| \|
\| Reviewed by Third Party \| No \| \| \| \|
\| Combination Product \| No \| \| \| \|
\| Predetermined Change
Control Plan Authorized \| No \| \| \| \| | Device Classification Name | Automated Radiological Image Processing Software | 510(k) Number | K252856 | Device Name | PeekMed web | Applicant | \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 | Applicant Contact | Sara Silva | Correspondent | \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 | Correspondent Contact | Sara Silva | Regulation Number | 892.2050 | Classification Product Code | \| QIH \| | QIH | Subsequent Product Code | \| LLZ \| | LLZ | Date Received | 09/09/2025 | Decision Date | 12/22/2025 | Decision | Substantially Equivalent 

(SESE) \| Regulation Medical Specialty \| Radiology \| 510k Review Panel \| Radiology \| Summary \| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252856.pdf) \| Type \| Traditional \| Reviewed by Third Party \| No \| Combination Product \| No \| Predetermined Change

Control Plan Authorized | No | |
| Device Classification Name | Automated Radiological Image Processing Software | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510(k) Number | K252856 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Device Name | PeekMed web | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant | \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Peek Health, S.A. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Braga, 

PT

4719-005 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant Contact | Sara Silva | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent | \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Peek Health, S.A. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Braga, 

PT

4719-005 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent Contact | Sara Silva | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Regulation Number | 892.2050 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification Product Code | \| QIH \| | QIH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| QIH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Subsequent Product Code | \| LLZ \| | LLZ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| LLZ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Date Received | 09/09/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision Date | 12/22/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision | Substantially Equivalent 

(SESE) \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|

| Regulation Medical Specialty | Radiology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510k Review Panel | Radiology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Summary | Summary | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Type | Traditional | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Reviewed by Third Party | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Combination Product | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Predetermined Change
Control Plan Authorized | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | New Search | Back To Search Results | | New Search | Back To Search Results | | \| Device Classification Name \| Automated Radiological Image Processing Software \| \| \| \|
\| --- \| --- \| \| \| \|
\| 510(k) Number \| K252856 \| \| \| \|
\| Device Name \| PeekMed web \| \| \| \|
\| Applicant \| \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| \| Peek Health, S.A. \| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| Braga, 

PT

4719-005 \|
\| Peek Health, S.A. \| \| \| \| \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| \| \| \| \|
\| Braga, 

PT

4719-005 \| \| \| \| \|
\| Applicant Contact \| Sara Silva \| \| \| \|
\| Correspondent \| \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| \| Peek Health, S.A. \| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| Braga, 

PT

4719-005 \|
\| Peek Health, S.A. \| \| \| \| \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| \| \| \| \|
\| Braga, 

PT

4719-005 \| \| \| \| \|
\| Correspondent Contact \| Sara Silva \| \| \| \|
\| Regulation Number \| 892.2050 \| \| \| \|
\| Classification Product Code \| \| QIH \| \| QIH \| \| \|
\| QIH \| \| \| \| \|
\| Subsequent Product Code \| \| LLZ \| \| LLZ \| \| \|
\| LLZ \| \| \| \| \|
\| Date Received \| 09/09/2025 \| \| \| \|
\| Decision Date \| 12/22/2025 \| \| \| \|
\| Decision \| Substantially Equivalent 

(SESE) \\|  \\|  \\|  \\|

\| Regulation Medical Specialty \| Radiology \| \| \| \|
\| 510k Review Panel \| Radiology \| \| \| \|
\| Summary \| Summary \| \| \| \|
\| Type \| Traditional \| \| \| \|
\| Reviewed by Third Party \| No \| \| \| \|
\| Combination Product \| No \| \| \| \|
\| Predetermined Change
Control Plan Authorized \| No \| \| \| \| | Device Classification Name | Automated Radiological Image Processing Software | 510(k) Number | K252856 | Device Name | PeekMed web | Applicant | \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 | Applicant Contact | Sara Silva | Correspondent | \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 | Correspondent Contact | Sara Silva | Regulation Number | 892.2050 | Classification Product Code | \| QIH \| | QIH | Subsequent Product Code | \| LLZ \| | LLZ | Date Received | 09/09/2025 | Decision Date | 12/22/2025 | Decision | Substantially Equivalent 

(SESE) \| Regulation Medical Specialty \| Radiology \| 510k Review Panel \| Radiology \| Summary \| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252856.pdf) \| Type \| Traditional \| Reviewed by Third Party \| No \| Combination Product \| No \| Predetermined Change

Control Plan Authorized | No |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Device Classification Name | Automated Radiological Image Processing Software | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510(k) Number | K252856 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Device Name | PeekMed web | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant | \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Peek Health, S.A. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Braga, 

PT

4719-005 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant Contact | Sara Silva | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent | \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Peek Health, S.A. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Braga, 

PT

4719-005 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent Contact | Sara Silva | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Regulation Number | 892.2050 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification Product Code | \| QIH \| | QIH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| QIH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Subsequent Product Code | \| LLZ \| | LLZ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| LLZ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Date Received | 09/09/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision Date | 12/22/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision | Substantially Equivalent 

(SESE) \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|

| Regulation Medical Specialty | Radiology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510k Review Panel | Radiology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Summary | Summary | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Type | Traditional | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Reviewed by Third Party | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Combination Product | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Predetermined Change
Control Plan Authorized | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Device Classification Name | Automated Radiological Image Processing Software | | | |
| --- | --- | | | |
| 510(k) Number | K252856 | | | |
| Device Name | PeekMed web | | | |
| Applicant | \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 |
| Peek Health, S.A. | | | | |
| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | | | | |
| Braga, 

PT

4719-005 | | | | |
| Applicant Contact | Sara Silva | | | |
| Correspondent | \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 |
| Peek Health, S.A. | | | | |
| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | | | | |
| Braga, 

PT

4719-005 | | | | |
| Correspondent Contact | Sara Silva | | | |
| Regulation Number | 892.2050 | | | |
| Classification Product Code | \| QIH \| | QIH | | |
| QIH | | | | |
| Subsequent Product Code | \| LLZ \| | LLZ | | |
| LLZ | | | | |
| Date Received | 09/09/2025 | | | |
| Decision Date | 12/22/2025 | | | |
| Decision | Substantially Equivalent 

(SESE) \|  \|  \|  \|

| Regulation Medical Specialty | Radiology | | | |
| 510k Review Panel | Radiology | | | |
| Summary | Summary | | | |
| Type | Traditional | | | |
| Reviewed by Third Party | No | | | |
| Combination Product | No | | | |
| Predetermined Change
Control Plan Authorized | No | | | | | Device Classification Name | Automated Radiological Image Processing Software | 510(k) Number | K252856 | Device Name | PeekMed web | Applicant | | Peek Health, S.A. |
| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas |
| Braga, 

PT

4719-005 | | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 | Applicant Contact | Sara Silva | Correspondent | | Peek Health, S.A. |
| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas |
| Braga, 

PT

4719-005 | | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 | Correspondent Contact | Sara Silva | Regulation Number | 892.2050 | Classification Product Code | | QIH | | QIH | Subsequent Product Code | | LLZ | | LLZ | Date Received | 09/09/2025 | Decision Date | 12/22/2025 | Decision | Substantially Equivalent 

(SESE) | Regulation Medical Specialty | Radiology | 510k Review Panel | Radiology | Summary | [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252856.pdf) | Type | Traditional | Reviewed by Third Party | No | Combination Product | No | Predetermined Change

Control Plan Authorized | No |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | New Search | Back To Search Results | | New Search | Back To Search Results | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| New Search | Back To Search Results | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | \| Device Classification Name \| Automated Radiological Image Processing Software \| \| \| \|
\| --- \| --- \| \| \| \|
\| 510(k) Number \| K252856 \| \| \| \|
\| Device Name \| PeekMed web \| \| \| \|
\| Applicant \| \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| \| Peek Health, S.A. \| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| Braga, 

PT

4719-005 \|
\| Peek Health, S.A. \| \| \| \| \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| \| \| \| \|
\| Braga, 

PT

4719-005 \| \| \| \| \|
\| Applicant Contact \| Sara Silva \| \| \| \|
\| Correspondent \| \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| \| Peek Health, S.A. \| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| Braga, 

PT

4719-005 \|
\| Peek Health, S.A. \| \| \| \| \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \| \| \| \| \|
\| Braga, 

PT

4719-005 \| \| \| \| \|
\| Correspondent Contact \| Sara Silva \| \| \| \|
\| Regulation Number \| 892.2050 \| \| \| \|
\| Classification Product Code \| \| QIH \| \| QIH \| \| \|
\| QIH \| \| \| \| \|
\| Subsequent Product Code \| \| LLZ \| \| LLZ \| \| \|
\| LLZ \| \| \| \| \|
\| Date Received \| 09/09/2025 \| \| \| \|
\| Decision Date \| 12/22/2025 \| \| \| \|
\| Decision \| Substantially Equivalent 

(SESE) \\|  \\|  \\|  \\|

\| Regulation Medical Specialty \| Radiology \| \| \| \|
\| 510k Review Panel \| Radiology \| \| \| \|
\| Summary \| Summary \| \| \| \|
\| Type \| Traditional \| \| \| \|
\| Reviewed by Third Party \| No \| \| \| \|
\| Combination Product \| No \| \| \| \|
\| Predetermined Change
Control Plan Authorized \| No \| \| \| \| | Device Classification Name | Automated Radiological Image Processing Software | 510(k) Number | K252856 | Device Name | PeekMed web | Applicant | \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 | Applicant Contact | Sara Silva | Correspondent | \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 | Correspondent Contact | Sara Silva | Regulation Number | 892.2050 | Classification Product Code | \| QIH \| | QIH | Subsequent Product Code | \| LLZ \| | LLZ | Date Received | 09/09/2025 | Decision Date | 12/22/2025 | Decision | Substantially Equivalent 

(SESE) \| Regulation Medical Specialty \| Radiology \| 510k Review Panel \| Radiology \| Summary \| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252856.pdf) \| Type \| Traditional \| Reviewed by Third Party \| No \| Combination Product \| No \| Predetermined Change

Control Plan Authorized | No |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Device Classification Name | Automated Radiological Image Processing Software | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510(k) Number | K252856 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Device Name | PeekMed web | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant | \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Peek Health, S.A. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Braga, 

PT

4719-005 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant Contact | Sara Silva | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent | \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Peek Health, S.A. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Braga, 

PT

4719-005 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent Contact | Sara Silva | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Regulation Number | 892.2050 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification Product Code | \| QIH \| | QIH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| QIH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Subsequent Product Code | \| LLZ \| | LLZ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| LLZ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Date Received | 09/09/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision Date | 12/22/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision | Substantially Equivalent 

(SESE) \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|  \|

| Regulation Medical Specialty | Radiology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510k Review Panel | Radiology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Summary | Summary | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Type | Traditional | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Reviewed by Third Party | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Combination Product | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Predetermined Change
Control Plan Authorized | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Device Classification Name | Automated Radiological Image Processing Software | | | |
| --- | --- | | | |
| 510(k) Number | K252856 | | | |
| Device Name | PeekMed web | | | |
| Applicant | \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 |
| Peek Health, S.A. | | | | |
| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | | | | |
| Braga, 

PT

4719-005 | | | | |
| Applicant Contact | Sara Silva | | | |
| Correspondent | \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 |
| Peek Health, S.A. | | | | |
| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | | | | |
| Braga, 

PT

4719-005 | | | | |
| Correspondent Contact | Sara Silva | | | |
| Regulation Number | 892.2050 | | | |
| Classification Product Code | \| QIH \| | QIH | | |
| QIH | | | | |
| Subsequent Product Code | \| LLZ \| | LLZ | | |
| LLZ | | | | |
| Date Received | 09/09/2025 | | | |
| Decision Date | 12/22/2025 | | | |
| Decision | Substantially Equivalent 

(SESE) \|  \|  \|  \|

| Regulation Medical Specialty | Radiology | | | |
| 510k Review Panel | Radiology | | | |
| Summary | Summary | | | |
| Type | Traditional | | | |
| Reviewed by Third Party | No | | | |
| Combination Product | No | | | |
| Predetermined Change
Control Plan Authorized | No | | | | | Device Classification Name | Automated Radiological Image Processing Software | 510(k) Number | K252856 | Device Name | PeekMed web | Applicant | | Peek Health, S.A. |
| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas |
| Braga, 

PT

4719-005 | | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 | Applicant Contact | Sara Silva | Correspondent | | Peek Health, S.A. |
| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas |
| Braga, 

PT

4719-005 | | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 | Correspondent Contact | Sara Silva | Regulation Number | 892.2050 | Classification Product Code | | QIH | | QIH | Subsequent Product Code | | LLZ | | LLZ | Date Received | 09/09/2025 | Decision Date | 12/22/2025 | Decision | Substantially Equivalent 

(SESE) | Regulation Medical Specialty | Radiology | 510k Review Panel | Radiology | Summary | [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252856.pdf) | Type | Traditional | Reviewed by Third Party | No | Combination Product | No | Predetermined Change

Control Plan Authorized | No | | | | |
| | Device Classification Name | Automated Radiological Image Processing Software | | | |
| --- | --- | | | |
| 510(k) Number | K252856 | | | |
| Device Name | PeekMed web | | | |
| Applicant | \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 |
| Peek Health, S.A. | | | | |
| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | | | | |
| Braga, 

PT

4719-005 | | | | |
| Applicant Contact | Sara Silva | | | |
| Correspondent | \| Peek Health, S.A. \|
\| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas \|
\| Braga, 

PT

4719-005 \| | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 |
| Peek Health, S.A. | | | | |
| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | | | | |
| Braga, 

PT

4719-005 | | | | |
| Correspondent Contact | Sara Silva | | | |
| Regulation Number | 892.2050 | | | |
| Classification Product Code | \| QIH \| | QIH | | |
| QIH | | | | |
| Subsequent Product Code | \| LLZ \| | LLZ | | |
| LLZ | | | | |
| Date Received | 09/09/2025 | | | |
| Decision Date | 12/22/2025 | | | |
| Decision | Substantially Equivalent 

(SESE) \|  \|  \|  \|

| Regulation Medical Specialty | Radiology | | | |
| 510k Review Panel | Radiology | | | |
| Summary | Summary | | | |
| Type | Traditional | | | |
| Reviewed by Third Party | No | | | |
| Combination Product | No | | | |
| Predetermined Change
Control Plan Authorized | No | | | | | Device Classification Name | Automated Radiological Image Processing Software | 510(k) Number | K252856 | Device Name | PeekMed web | Applicant | | Peek Health, S.A. |
| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas |
| Braga, 

PT

4719-005 | | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 | Applicant Contact | Sara Silva | Correspondent | | Peek Health, S.A. |
| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas |
| Braga, 

PT

4719-005 | | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 | Correspondent Contact | Sara Silva | Regulation Number | 892.2050 | Classification Product Code | | QIH | | QIH | Subsequent Product Code | | LLZ | | LLZ | Date Received | 09/09/2025 | Decision Date | 12/22/2025 | Decision | Substantially Equivalent 

(SESE) | Regulation Medical Specialty | Radiology | 510k Review Panel | Radiology | Summary | [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252856.pdf) | Type | Traditional | Reviewed by Third Party | No | Combination Product | No | Predetermined Change

Control Plan Authorized | No | | | | | |
| Device Classification Name | Automated Radiological Image Processing Software | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510(k) Number | K252856 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Device Name | PeekMed web | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant | | Peek Health, S.A. |
| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas |
| Braga, 

PT

4719-005 | | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Peek Health, S.A. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Braga, 

PT

4719-005 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant Contact | Sara Silva | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent | | Peek Health, S.A. |
| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas |
| Braga, 

PT

4719-005 | | Peek Health, S.A. | Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | Braga, 

PT

4719-005 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Peek Health, S.A. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Centro De Negócios Ideia Atlântico, Rua Padres Carmelitas | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Braga, 

PT

4719-005 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent Contact | Sara Silva | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Regulation Number | 892.2050 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification Product Code | | QIH | | QIH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| QIH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Subsequent Product Code | | LLZ | | LLZ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| LLZ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Date Received | 09/09/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision Date | 12/22/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision | Substantially Equivalent 

(SESE) |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |

| Regulation Medical Specialty | Radiology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510k Review Panel | Radiology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Summary | Summary | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Type | Traditional | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Reviewed by Third Party | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Combination Product | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Predetermined Change

Control Plan Authorized | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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Source

Favicon for www.fda.gov
FDA AI-Enabled Medical Devices fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices
Pharma & Drug Safety
Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
K252856

Who this affects

Applies to
Manufacturers Healthcare providers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical Device Approval
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Compliance
Compliance frameworks
FDA 21 CFR Part 11
Topics
Artificial Intelligence Software as a Medical Device

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