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FDA ART-Plan+ Medical Device Premarket Notification

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Detected March 23rd, 2026
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Summary

The FDA has published a premarket notification (510(k)) for the ART-Plan+ medical device. This notification details the device's compliance with regulatory requirements for market entry. The document is part of the FDA's public database for medical device approvals.

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What changed

This document is a 510(k) premarket notification for the ART-Plan+ medical device, submitted to the U.S. Food and Drug Administration (FDA). It serves as a public record of the device's clearance for marketing, indicating it is substantially equivalent to a legally marketed predicate device. The notification is part of the FDA's ongoing efforts to regulate medical devices, including those incorporating AI.

For medical device manufacturers, this notification signifies a completed regulatory step for a specific product. It provides transparency into the FDA's review process for AI-enabled devices. Compliance officers should note this as an example of a cleared device, relevant for understanding the regulatory landscape for AI in medical technology.

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 \| System, Planning, Radiation Therapy Treatment \| \| \| \|
\| --- \| --- \| \| \| \|
\| 510(k) Number \| K253091 \| \| \| \|
\| Device Name \| ART-Plan+ (v3.1.0) \| \| \| \|
\| Applicant \| \\| Therapanacea Sas \\|
\\| 7 Bis Blvd. Bourdon \\|
\\| Paris, 

FR

75004 \\| \| Therapanacea Sas \| 7 Bis Blvd. Bourdon \| Paris, 

FR

75004 \|
\| Therapanacea Sas \| \| \| \| \|
\| 7 Bis Blvd. Bourdon \| \| \| \| \|
\| Paris, 

FR

75004 \| \| \| \| \|
\| Applicant Contact \| Ajachandra Bhairavi \| \| \| \|
\| Correspondent \| \\| Therapanacea Sas \\|
\\| 7 Bis Blvd. Bourdon \\|
\\| Paris, 

FR

75004 \\| \| Therapanacea Sas \| 7 Bis Blvd. Bourdon \| Paris, 

FR

75004 \|
\| Therapanacea Sas \| \| \| \| \|
\| 7 Bis Blvd. Bourdon \| \| \| \| \|
\| Paris, 

FR

75004 \| \| \| \| \|
\| Correspondent Contact \| Ajachandra Bhairavi \| \| \| \|
\| Regulation Number \| 892.5050 \| \| \| \|
\| Classification Product Code \| \\| MUJ \\| \| MUJ \| \| \|
\| MUJ \| \| \| \| \|
\| Subsequent Product Codes \| \\| LLZ \\| QKB \\| \| LLZ \| QKB \| \|
\| LLZ \| QKB \| \| \| \|
\| Date Received \| 09/23/2025 \| \| \| \|
\| Decision Date \| 12/23/2025 \| \| \| \|
\| 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 \| System, Planning, Radiation Therapy Treatment \| 510(k) Number \| K253091 \| Device Name \| ART-Plan+ (v3.1.0) \| Applicant \| \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| \| Therapanacea Sas \| 7 Bis Blvd. Bourdon \| Paris, 

FR

75004 \| Applicant Contact \| Ajachandra Bhairavi \| Correspondent \| \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| \| Therapanacea Sas \| 7 Bis Blvd. Bourdon \| Paris, 

FR

75004 \| Correspondent Contact \| Ajachandra Bhairavi \| Regulation Number \| 892.5050 \| Classification Product Code \| \| MUJ \| \| MUJ \| Subsequent Product Codes \| \| LLZ \| QKB \| \| LLZ \| QKB \| Date Received \| 09/23/2025 \| Decision Date \| 12/23/2025 \| Decision \| Substantially Equivalent 

(SESE) \\| Regulation Medical Specialty \\| Radiology \\| 510k Review Panel \\| Radiology \\| Summary \\| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253091.pdf) \\| Type \\| Traditional \\| Reviewed by Third Party \\| No \\| Combination Product \\| No \\| Predetermined Change

Control Plan Authorized \| No \|
\| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \|
\| Device Classification Name \| System, Planning, Radiation Therapy Treatment \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| 510(k) Number \| K253091 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Device Name \| ART-Plan+ (v3.1.0) \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Applicant \| \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| \| Therapanacea Sas \| 7 Bis Blvd. Bourdon \| Paris, 

FR

75004 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Therapanacea Sas \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| 7 Bis Blvd. Bourdon \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Paris, 

FR

75004 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Applicant Contact \| Ajachandra Bhairavi \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Correspondent \| \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| \| Therapanacea Sas \| 7 Bis Blvd. Bourdon \| Paris, 

FR

75004 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Therapanacea Sas \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| 7 Bis Blvd. Bourdon \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Paris, 

FR

75004 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Correspondent Contact \| Ajachandra Bhairavi \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Regulation Number \| 892.5050 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Classification Product Code \| \| MUJ \| \| MUJ \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| MUJ \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Subsequent Product Codes \| \| LLZ \| QKB \| \| LLZ \| QKB \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| LLZ \| QKB \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Date Received \| 09/23/2025 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Decision Date \| 12/23/2025 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| 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 \| System, Planning, Radiation Therapy Treatment \| \| \| \|
\| --- \| --- \| \| \| \|
\| 510(k) Number \| K253091 \| \| \| \|
\| Device Name \| ART-Plan+ (v3.1.0) \| \| \| \|
\| Applicant \| \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| \| Therapanacea Sas \| 7 Bis Blvd. Bourdon \| Paris, 

FR

75004 \|
\| Therapanacea Sas \| \| \| \| \|
\| 7 Bis Blvd. Bourdon \| \| \| \| \|
\| Paris, 

FR

75004 \| \| \| \| \|
\| Applicant Contact \| Ajachandra Bhairavi \| \| \| \|
\| Correspondent \| \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| \| Therapanacea Sas \| 7 Bis Blvd. Bourdon \| Paris, 

FR

75004 \|
\| Therapanacea Sas \| \| \| \| \|
\| 7 Bis Blvd. Bourdon \| \| \| \| \|
\| Paris, 

FR

75004 \| \| \| \| \|
\| Correspondent Contact \| Ajachandra Bhairavi \| \| \| \|
\| Regulation Number \| 892.5050 \| \| \| \|
\| Classification Product Code \| \| MUJ \| \| MUJ \| \| \|
\| MUJ \| \| \| \| \|
\| Subsequent Product Codes \| \| LLZ \| QKB \| \| LLZ \| QKB \| \|
\| LLZ \| QKB \| \| \| \|
\| Date Received \| 09/23/2025 \| \| \| \|
\| Decision Date \| 12/23/2025 \| \| \| \|
\| 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 | System, Planning, Radiation Therapy Treatment | 510(k) Number | K253091 | Device Name | ART-Plan+ (v3.1.0) | Applicant | \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 | Applicant Contact | Ajachandra Bhairavi | Correspondent | \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 | Correspondent Contact | Ajachandra Bhairavi | Regulation Number | 892.5050 | Classification Product Code | \| MUJ \| | MUJ | Subsequent Product Codes | \| LLZ \| QKB \| | LLZ | QKB | Date Received | 09/23/2025 | Decision Date | 12/23/2025 | Decision | Substantially Equivalent 

(SESE) \| Regulation Medical Specialty \| Radiology \| 510k Review Panel \| Radiology \| Summary \| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253091.pdf) \| Type \| Traditional \| Reviewed by Third Party \| No \| Combination Product \| No \| Predetermined Change

Control Plan Authorized | No |
| \| Device Classification Name \| System, Planning, Radiation Therapy Treatment \| \| \| \|
\| --- \| --- \| \| \| \|
\| 510(k) Number \| K253091 \| \| \| \|
\| Device Name \| ART-Plan+ (v3.1.0) \| \| \| \|
\| Applicant \| \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| \| Therapanacea Sas \| 7 Bis Blvd. Bourdon \| Paris, 

FR

75004 \|
\| Therapanacea Sas \| \| \| \| \|
\| 7 Bis Blvd. Bourdon \| \| \| \| \|
\| Paris, 

FR

75004 \| \| \| \| \|
\| Applicant Contact \| Ajachandra Bhairavi \| \| \| \|
\| Correspondent \| \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| \| Therapanacea Sas \| 7 Bis Blvd. Bourdon \| Paris, 

FR

75004 \|
\| Therapanacea Sas \| \| \| \| \|
\| 7 Bis Blvd. Bourdon \| \| \| \| \|
\| Paris, 

FR

75004 \| \| \| \| \|
\| Correspondent Contact \| Ajachandra Bhairavi \| \| \| \|
\| Regulation Number \| 892.5050 \| \| \| \|
\| Classification Product Code \| \| MUJ \| \| MUJ \| \| \|
\| MUJ \| \| \| \| \|
\| Subsequent Product Codes \| \| LLZ \| QKB \| \| LLZ \| QKB \| \|
\| LLZ \| QKB \| \| \| \|
\| Date Received \| 09/23/2025 \| \| \| \|
\| Decision Date \| 12/23/2025 \| \| \| \|
\| 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 | System, Planning, Radiation Therapy Treatment | 510(k) Number | K253091 | Device Name | ART-Plan+ (v3.1.0) | Applicant | \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 | Applicant Contact | Ajachandra Bhairavi | Correspondent | \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 | Correspondent Contact | Ajachandra Bhairavi | Regulation Number | 892.5050 | Classification Product Code | \| MUJ \| | MUJ | Subsequent Product Codes | \| LLZ \| QKB \| | LLZ | QKB | Date Received | 09/23/2025 | Decision Date | 12/23/2025 | Decision | Substantially Equivalent 

(SESE) \| Regulation Medical Specialty \| Radiology \| 510k Review Panel \| Radiology \| Summary \| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253091.pdf) \| Type \| Traditional \| Reviewed by Third Party \| No \| Combination Product \| No \| Predetermined Change

Control Plan Authorized | No | |
| Device Classification Name | System, Planning, Radiation Therapy Treatment | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510(k) Number | K253091 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Device Name | ART-Plan+ (v3.1.0) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant | \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Therapanacea Sas | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 7 Bis Blvd. Bourdon | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Paris, 

FR

75004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant Contact | Ajachandra Bhairavi | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent | \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Therapanacea Sas | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 7 Bis Blvd. Bourdon | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Paris, 

FR

75004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent Contact | Ajachandra Bhairavi | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Regulation Number | 892.5050 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification Product Code | \| MUJ \| | MUJ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| MUJ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Subsequent Product Codes | \| LLZ \| QKB \| | LLZ | QKB | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| LLZ | QKB | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Date Received | 09/23/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision Date | 12/23/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 \| System, Planning, Radiation Therapy Treatment \| \| \| \|
\| --- \| --- \| \| \| \|
\| 510(k) Number \| K253091 \| \| \| \|
\| Device Name \| ART-Plan+ (v3.1.0) \| \| \| \|
\| Applicant \| \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| \| Therapanacea Sas \| 7 Bis Blvd. Bourdon \| Paris, 

FR

75004 \|
\| Therapanacea Sas \| \| \| \| \|
\| 7 Bis Blvd. Bourdon \| \| \| \| \|
\| Paris, 

FR

75004 \| \| \| \| \|
\| Applicant Contact \| Ajachandra Bhairavi \| \| \| \|
\| Correspondent \| \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| \| Therapanacea Sas \| 7 Bis Blvd. Bourdon \| Paris, 

FR

75004 \|
\| Therapanacea Sas \| \| \| \| \|
\| 7 Bis Blvd. Bourdon \| \| \| \| \|
\| Paris, 

FR

75004 \| \| \| \| \|
\| Correspondent Contact \| Ajachandra Bhairavi \| \| \| \|
\| Regulation Number \| 892.5050 \| \| \| \|
\| Classification Product Code \| \| MUJ \| \| MUJ \| \| \|
\| MUJ \| \| \| \| \|
\| Subsequent Product Codes \| \| LLZ \| QKB \| \| LLZ \| QKB \| \|
\| LLZ \| QKB \| \| \| \|
\| Date Received \| 09/23/2025 \| \| \| \|
\| Decision Date \| 12/23/2025 \| \| \| \|
\| 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 | System, Planning, Radiation Therapy Treatment | 510(k) Number | K253091 | Device Name | ART-Plan+ (v3.1.0) | Applicant | \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 | Applicant Contact | Ajachandra Bhairavi | Correspondent | \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 | Correspondent Contact | Ajachandra Bhairavi | Regulation Number | 892.5050 | Classification Product Code | \| MUJ \| | MUJ | Subsequent Product Codes | \| LLZ \| QKB \| | LLZ | QKB | Date Received | 09/23/2025 | Decision Date | 12/23/2025 | Decision | Substantially Equivalent 

(SESE) \| Regulation Medical Specialty \| Radiology \| 510k Review Panel \| Radiology \| Summary \| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253091.pdf) \| Type \| Traditional \| Reviewed by Third Party \| No \| Combination Product \| No \| Predetermined Change

Control Plan Authorized | No |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Device Classification Name | System, Planning, Radiation Therapy Treatment | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510(k) Number | K253091 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Device Name | ART-Plan+ (v3.1.0) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant | \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Therapanacea Sas | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 7 Bis Blvd. Bourdon | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Paris, 

FR

75004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant Contact | Ajachandra Bhairavi | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent | \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Therapanacea Sas | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 7 Bis Blvd. Bourdon | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Paris, 

FR

75004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent Contact | Ajachandra Bhairavi | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Regulation Number | 892.5050 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification Product Code | \| MUJ \| | MUJ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| MUJ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Subsequent Product Codes | \| LLZ \| QKB \| | LLZ | QKB | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| LLZ | QKB | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Date Received | 09/23/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision Date | 12/23/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 | System, Planning, Radiation Therapy Treatment | | | |
| --- | --- | | | |
| 510(k) Number | K253091 | | | |
| Device Name | ART-Plan+ (v3.1.0) | | | |
| Applicant | \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 |
| Therapanacea Sas | | | | |
| 7 Bis Blvd. Bourdon | | | | |
| Paris, 

FR

75004 | | | | |
| Applicant Contact | Ajachandra Bhairavi | | | |
| Correspondent | \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 |
| Therapanacea Sas | | | | |
| 7 Bis Blvd. Bourdon | | | | |
| Paris, 

FR

75004 | | | | |
| Correspondent Contact | Ajachandra Bhairavi | | | |
| Regulation Number | 892.5050 | | | |
| Classification Product Code | \| MUJ \| | MUJ | | |
| MUJ | | | | |
| Subsequent Product Codes | \| LLZ \| QKB \| | LLZ | QKB | |
| LLZ | QKB | | | |
| Date Received | 09/23/2025 | | | |
| Decision Date | 12/23/2025 | | | |
| 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 | System, Planning, Radiation Therapy Treatment | 510(k) Number | K253091 | Device Name | ART-Plan+ (v3.1.0) | Applicant | | Therapanacea Sas |
| 7 Bis Blvd. Bourdon |
| Paris, 

FR

75004 | | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 | Applicant Contact | Ajachandra Bhairavi | Correspondent | | Therapanacea Sas |
| 7 Bis Blvd. Bourdon |
| Paris, 

FR

75004 | | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 | Correspondent Contact | Ajachandra Bhairavi | Regulation Number | 892.5050 | Classification Product Code | | MUJ | | MUJ | Subsequent Product Codes | | LLZ | QKB | | LLZ | QKB | Date Received | 09/23/2025 | Decision Date | 12/23/2025 | Decision | Substantially Equivalent 

(SESE) | Regulation Medical Specialty | Radiology | 510k Review Panel | Radiology | Summary | [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253091.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 \| System, Planning, Radiation Therapy Treatment \| \| \| \|
\| --- \| --- \| \| \| \|
\| 510(k) Number \| K253091 \| \| \| \|
\| Device Name \| ART-Plan+ (v3.1.0) \| \| \| \|
\| Applicant \| \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| \| Therapanacea Sas \| 7 Bis Blvd. Bourdon \| Paris, 

FR

75004 \|
\| Therapanacea Sas \| \| \| \| \|
\| 7 Bis Blvd. Bourdon \| \| \| \| \|
\| Paris, 

FR

75004 \| \| \| \| \|
\| Applicant Contact \| Ajachandra Bhairavi \| \| \| \|
\| Correspondent \| \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| \| Therapanacea Sas \| 7 Bis Blvd. Bourdon \| Paris, 

FR

75004 \|
\| Therapanacea Sas \| \| \| \| \|
\| 7 Bis Blvd. Bourdon \| \| \| \| \|
\| Paris, 

FR

75004 \| \| \| \| \|
\| Correspondent Contact \| Ajachandra Bhairavi \| \| \| \|
\| Regulation Number \| 892.5050 \| \| \| \|
\| Classification Product Code \| \| MUJ \| \| MUJ \| \| \|
\| MUJ \| \| \| \| \|
\| Subsequent Product Codes \| \| LLZ \| QKB \| \| LLZ \| QKB \| \|
\| LLZ \| QKB \| \| \| \|
\| Date Received \| 09/23/2025 \| \| \| \|
\| Decision Date \| 12/23/2025 \| \| \| \|
\| 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 | System, Planning, Radiation Therapy Treatment | 510(k) Number | K253091 | Device Name | ART-Plan+ (v3.1.0) | Applicant | \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 | Applicant Contact | Ajachandra Bhairavi | Correspondent | \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 | Correspondent Contact | Ajachandra Bhairavi | Regulation Number | 892.5050 | Classification Product Code | \| MUJ \| | MUJ | Subsequent Product Codes | \| LLZ \| QKB \| | LLZ | QKB | Date Received | 09/23/2025 | Decision Date | 12/23/2025 | Decision | Substantially Equivalent 

(SESE) \| Regulation Medical Specialty \| Radiology \| 510k Review Panel \| Radiology \| Summary \| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253091.pdf) \| Type \| Traditional \| Reviewed by Third Party \| No \| Combination Product \| No \| Predetermined Change

Control Plan Authorized | No |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Device Classification Name | System, Planning, Radiation Therapy Treatment | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510(k) Number | K253091 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Device Name | ART-Plan+ (v3.1.0) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant | \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Therapanacea Sas | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 7 Bis Blvd. Bourdon | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Paris, 

FR

75004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant Contact | Ajachandra Bhairavi | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent | \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Therapanacea Sas | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 7 Bis Blvd. Bourdon | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Paris, 

FR

75004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent Contact | Ajachandra Bhairavi | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Regulation Number | 892.5050 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification Product Code | \| MUJ \| | MUJ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| MUJ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Subsequent Product Codes | \| LLZ \| QKB \| | LLZ | QKB | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| LLZ | QKB | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Date Received | 09/23/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision Date | 12/23/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 | System, Planning, Radiation Therapy Treatment | | | |
| --- | --- | | | |
| 510(k) Number | K253091 | | | |
| Device Name | ART-Plan+ (v3.1.0) | | | |
| Applicant | \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 |
| Therapanacea Sas | | | | |
| 7 Bis Blvd. Bourdon | | | | |
| Paris, 

FR

75004 | | | | |
| Applicant Contact | Ajachandra Bhairavi | | | |
| Correspondent | \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 |
| Therapanacea Sas | | | | |
| 7 Bis Blvd. Bourdon | | | | |
| Paris, 

FR

75004 | | | | |
| Correspondent Contact | Ajachandra Bhairavi | | | |
| Regulation Number | 892.5050 | | | |
| Classification Product Code | \| MUJ \| | MUJ | | |
| MUJ | | | | |
| Subsequent Product Codes | \| LLZ \| QKB \| | LLZ | QKB | |
| LLZ | QKB | | | |
| Date Received | 09/23/2025 | | | |
| Decision Date | 12/23/2025 | | | |
| 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 | System, Planning, Radiation Therapy Treatment | 510(k) Number | K253091 | Device Name | ART-Plan+ (v3.1.0) | Applicant | | Therapanacea Sas |
| 7 Bis Blvd. Bourdon |
| Paris, 

FR

75004 | | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 | Applicant Contact | Ajachandra Bhairavi | Correspondent | | Therapanacea Sas |
| 7 Bis Blvd. Bourdon |
| Paris, 

FR

75004 | | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 | Correspondent Contact | Ajachandra Bhairavi | Regulation Number | 892.5050 | Classification Product Code | | MUJ | | MUJ | Subsequent Product Codes | | LLZ | QKB | | LLZ | QKB | Date Received | 09/23/2025 | Decision Date | 12/23/2025 | Decision | Substantially Equivalent 

(SESE) | Regulation Medical Specialty | Radiology | 510k Review Panel | Radiology | Summary | [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253091.pdf) | Type | Traditional | Reviewed by Third Party | No | Combination Product | No | Predetermined Change

Control Plan Authorized | No | | | | |
| | Device Classification Name | System, Planning, Radiation Therapy Treatment | | | |
| --- | --- | | | |
| 510(k) Number | K253091 | | | |
| Device Name | ART-Plan+ (v3.1.0) | | | |
| Applicant | \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 |
| Therapanacea Sas | | | | |
| 7 Bis Blvd. Bourdon | | | | |
| Paris, 

FR

75004 | | | | |
| Applicant Contact | Ajachandra Bhairavi | | | |
| Correspondent | \| Therapanacea Sas \|
\| 7 Bis Blvd. Bourdon \|
\| Paris, 

FR

75004 \| | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 |
| Therapanacea Sas | | | | |
| 7 Bis Blvd. Bourdon | | | | |
| Paris, 

FR

75004 | | | | |
| Correspondent Contact | Ajachandra Bhairavi | | | |
| Regulation Number | 892.5050 | | | |
| Classification Product Code | \| MUJ \| | MUJ | | |
| MUJ | | | | |
| Subsequent Product Codes | \| LLZ \| QKB \| | LLZ | QKB | |
| LLZ | QKB | | | |
| Date Received | 09/23/2025 | | | |
| Decision Date | 12/23/2025 | | | |
| 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 | System, Planning, Radiation Therapy Treatment | 510(k) Number | K253091 | Device Name | ART-Plan+ (v3.1.0) | Applicant | | Therapanacea Sas |
| 7 Bis Blvd. Bourdon |
| Paris, 

FR

75004 | | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 | Applicant Contact | Ajachandra Bhairavi | Correspondent | | Therapanacea Sas |
| 7 Bis Blvd. Bourdon |
| Paris, 

FR

75004 | | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 | Correspondent Contact | Ajachandra Bhairavi | Regulation Number | 892.5050 | Classification Product Code | | MUJ | | MUJ | Subsequent Product Codes | | LLZ | QKB | | LLZ | QKB | Date Received | 09/23/2025 | Decision Date | 12/23/2025 | Decision | Substantially Equivalent 

(SESE) | Regulation Medical Specialty | Radiology | 510k Review Panel | Radiology | Summary | [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253091.pdf) | Type | Traditional | Reviewed by Third Party | No | Combination Product | No | Predetermined Change

Control Plan Authorized | No | | | | | |
| Device Classification Name | System, Planning, Radiation Therapy Treatment | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510(k) Number | K253091 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Device Name | ART-Plan+ (v3.1.0) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant | | Therapanacea Sas |
| 7 Bis Blvd. Bourdon |
| Paris, 

FR

75004 | | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Therapanacea Sas | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 7 Bis Blvd. Bourdon | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Paris, 

FR

75004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant Contact | Ajachandra Bhairavi | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent | | Therapanacea Sas |
| 7 Bis Blvd. Bourdon |
| Paris, 

FR

75004 | | Therapanacea Sas | 7 Bis Blvd. Bourdon | Paris, 

FR

75004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Therapanacea Sas | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 7 Bis Blvd. Bourdon | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Paris, 

FR

75004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent Contact | Ajachandra Bhairavi | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Regulation Number | 892.5050 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification Product Code | | MUJ | | MUJ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| MUJ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Subsequent Product Codes | | LLZ | QKB | | LLZ | QKB | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| LLZ | QKB | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Date Received | 09/23/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision Date | 12/23/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

Named provisions

510(k) Premarket Notification

Related changes

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Routine Mar 23, 2026 • ChangeBridge: Trademarks - Medical Services (Class 044) • Healthcare

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
K253091

Who this affects

Applies to
Medical device makers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Medical Device Approval
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Regulatory Affairs
Topics
Medical Devices Artificial Intelligence

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