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FDA K253532: TruSPECT Processing Station Submission

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Detected March 23rd, 2026
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Summary

The FDA has published a 510(k) premarket notification submission for the TruSPECT Processing Station, identified by K253532. This notification indicates a new device is being reviewed or has been cleared by the FDA.

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What changed

The FDA has posted a 510(k) premarket notification submission for the TruSPECT Processing Station, identified by the submission number K253532. This entry on the FDA's database signifies that a medical device manufacturer has submitted documentation for review, seeking clearance to market the device. The specific details of the device's intended use, technological characteristics, and the FDA's determination are typically available through the provided URL.

For compliance officers, this notification serves as an indicator of new or updated medical device market activity. While this specific entry does not impose new obligations, it highlights the ongoing regulatory review process for medical devices, particularly those involving processing stations. Companies involved in the manufacturing or distribution of similar equipment should be aware of such submissions as they can signal emerging technologies or competitive landscape changes within the medical device sector.

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 \| K253532 \| \| \| \|
\| Device Name \| TruSPECT Processing Station \| \| \| \|
\| Applicant \| \\| Spectrum Dynamics Medical, Ltd. \\|
\\| 22 Bareket St. N. Industrial Park \\|
\\| Caesarea, 

IL

3079837 \\| \| Spectrum Dynamics Medical, Ltd. \| 22 Bareket St. N. Industrial Park \| Caesarea, 

IL

3079837 \|
\| Spectrum Dynamics Medical, Ltd. \| \| \| \| \|
\| 22 Bareket St. N. Industrial Park \| \| \| \| \|
\| Caesarea, 

IL

3079837 \| \| \| \| \|
\| Applicant Contact \| Igor Naroditsky \| \| \| \|
\| Correspondent \| \\| Spectrum Dynamics Medical, Ltd. \\|
\\| 22 Bareket St. N. Industrial Park \\|
\\| Caesarea, 

IL

3079837 \\| \| Spectrum Dynamics Medical, Ltd. \| 22 Bareket St. N. Industrial Park \| Caesarea, 

IL

3079837 \|
\| Spectrum Dynamics Medical, Ltd. \| \| \| \| \|
\| 22 Bareket St. N. Industrial Park \| \| \| \| \|
\| Caesarea, 

IL

3079837 \| \| \| \| \|
\| Correspondent Contact \| Igor Naroditsky \| \| \| \|
\| Regulation Number \| 892.2050 \| \| \| \|
\| Classification Product Code \| \\| QIH \\| \| QIH \| \| \|
\| QIH \| \| \| \| \|
\| Subsequent Product Code \| \\| LLZ \\| \| LLZ \| \| \|
\| LLZ \| \| \| \| \|
\| Date Received \| 11/13/2025 \| \| \| \|
\| Decision Date \| 12/30/2025 \| \| \| \|
\| Decision \| Substantially Equivalent 

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

\| Regulation Medical Specialty \| Radiology \| \| \| \|
\| 510k Review Panel \| Radiology \| \| \| \|
\| Summary \| Summary \| \| \| \|
\| Type \| Special \| \| \| \|
\| 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 \| K253532 \| Device Name \| TruSPECT Processing Station \| Applicant \| \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| \| Spectrum Dynamics Medical, Ltd. \| 22 Bareket St. N. Industrial Park \| Caesarea, 

IL

3079837 \| Applicant Contact \| Igor Naroditsky \| Correspondent \| \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| \| Spectrum Dynamics Medical, Ltd. \| 22 Bareket St. N. Industrial Park \| Caesarea, 

IL

3079837 \| Correspondent Contact \| Igor Naroditsky \| Regulation Number \| 892.2050 \| Classification Product Code \| \| QIH \| \| QIH \| Subsequent Product Code \| \| LLZ \| \| LLZ \| Date Received \| 11/13/2025 \| Decision Date \| 12/30/2025 \| Decision \| Substantially Equivalent 

(SESE) \\| Regulation Medical Specialty \\| Radiology \\| 510k Review Panel \\| Radiology \\| Summary \\| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253532.pdf) \\| Type \\| Special \\| 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 \| K253532 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Device Name \| TruSPECT Processing Station \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Applicant \| \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| \| Spectrum Dynamics Medical, Ltd. \| 22 Bareket St. N. Industrial Park \| Caesarea, 

IL

3079837 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Spectrum Dynamics Medical, Ltd. \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| 22 Bareket St. N. Industrial Park \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Caesarea, 

IL

3079837 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Applicant Contact \| Igor Naroditsky \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Correspondent \| \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| \| Spectrum Dynamics Medical, Ltd. \| 22 Bareket St. N. Industrial Park \| Caesarea, 

IL

3079837 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Spectrum Dynamics Medical, Ltd. \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| 22 Bareket St. N. Industrial Park \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Caesarea, 

IL

3079837 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Correspondent Contact \| Igor Naroditsky \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Regulation Number \| 892.2050 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Classification Product Code \| \| QIH \| \| QIH \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| QIH \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Subsequent Product Code \| \| LLZ \| \| LLZ \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| LLZ \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Date Received \| 11/13/2025 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Decision Date \| 12/30/2025 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Decision \| Substantially Equivalent 

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

\| Regulation Medical Specialty \| Radiology \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| 510k Review Panel \| Radiology \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Summary \| Summary \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Type \| Special \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| 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 \| K253532 \| \| \| \|
\| Device Name \| TruSPECT Processing Station \| \| \| \|
\| Applicant \| \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| \| Spectrum Dynamics Medical, Ltd. \| 22 Bareket St. N. Industrial Park \| Caesarea, 

IL

3079837 \|
\| Spectrum Dynamics Medical, Ltd. \| \| \| \| \|
\| 22 Bareket St. N. Industrial Park \| \| \| \| \|
\| Caesarea, 

IL

3079837 \| \| \| \| \|
\| Applicant Contact \| Igor Naroditsky \| \| \| \|
\| Correspondent \| \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| \| Spectrum Dynamics Medical, Ltd. \| 22 Bareket St. N. Industrial Park \| Caesarea, 

IL

3079837 \|
\| Spectrum Dynamics Medical, Ltd. \| \| \| \| \|
\| 22 Bareket St. N. Industrial Park \| \| \| \| \|
\| Caesarea, 

IL

3079837 \| \| \| \| \|
\| Correspondent Contact \| Igor Naroditsky \| \| \| \|
\| Regulation Number \| 892.2050 \| \| \| \|
\| Classification Product Code \| \| QIH \| \| QIH \| \| \|
\| QIH \| \| \| \| \|
\| Subsequent Product Code \| \| LLZ \| \| LLZ \| \| \|
\| LLZ \| \| \| \| \|
\| Date Received \| 11/13/2025 \| \| \| \|
\| Decision Date \| 12/30/2025 \| \| \| \|
\| Decision \| Substantially Equivalent 

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

\| Regulation Medical Specialty \| Radiology \| \| \| \|
\| 510k Review Panel \| Radiology \| \| \| \|
\| Summary \| Summary \| \| \| \|
\| Type \| Special \| \| \| \|
\| 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 | K253532 | Device Name | TruSPECT Processing Station | Applicant | \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 | Applicant Contact | Igor Naroditsky | Correspondent | \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 | Correspondent Contact | Igor Naroditsky | Regulation Number | 892.2050 | Classification Product Code | \| QIH \| | QIH | Subsequent Product Code | \| LLZ \| | LLZ | Date Received | 11/13/2025 | Decision Date | 12/30/2025 | Decision | Substantially Equivalent 

(SESE) \| Regulation Medical Specialty \| Radiology \| 510k Review Panel \| Radiology \| Summary \| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253532.pdf) \| Type \| Special \| 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 \| K253532 \| \| \| \|
\| Device Name \| TruSPECT Processing Station \| \| \| \|
\| Applicant \| \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| \| Spectrum Dynamics Medical, Ltd. \| 22 Bareket St. N. Industrial Park \| Caesarea, 

IL

3079837 \|
\| Spectrum Dynamics Medical, Ltd. \| \| \| \| \|
\| 22 Bareket St. N. Industrial Park \| \| \| \| \|
\| Caesarea, 

IL

3079837 \| \| \| \| \|
\| Applicant Contact \| Igor Naroditsky \| \| \| \|
\| Correspondent \| \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| \| Spectrum Dynamics Medical, Ltd. \| 22 Bareket St. N. Industrial Park \| Caesarea, 

IL

3079837 \|
\| Spectrum Dynamics Medical, Ltd. \| \| \| \| \|
\| 22 Bareket St. N. Industrial Park \| \| \| \| \|
\| Caesarea, 

IL

3079837 \| \| \| \| \|
\| Correspondent Contact \| Igor Naroditsky \| \| \| \|
\| Regulation Number \| 892.2050 \| \| \| \|
\| Classification Product Code \| \| QIH \| \| QIH \| \| \|
\| QIH \| \| \| \| \|
\| Subsequent Product Code \| \| LLZ \| \| LLZ \| \| \|
\| LLZ \| \| \| \| \|
\| Date Received \| 11/13/2025 \| \| \| \|
\| Decision Date \| 12/30/2025 \| \| \| \|
\| Decision \| Substantially Equivalent 

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

\| Regulation Medical Specialty \| Radiology \| \| \| \|
\| 510k Review Panel \| Radiology \| \| \| \|
\| Summary \| Summary \| \| \| \|
\| Type \| Special \| \| \| \|
\| 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 | K253532 | Device Name | TruSPECT Processing Station | Applicant | \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 | Applicant Contact | Igor Naroditsky | Correspondent | \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 | Correspondent Contact | Igor Naroditsky | Regulation Number | 892.2050 | Classification Product Code | \| QIH \| | QIH | Subsequent Product Code | \| LLZ \| | LLZ | Date Received | 11/13/2025 | Decision Date | 12/30/2025 | Decision | Substantially Equivalent 

(SESE) \| Regulation Medical Specialty \| Radiology \| 510k Review Panel \| Radiology \| Summary \| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253532.pdf) \| Type \| Special \| 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 | K253532 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Device Name | TruSPECT Processing Station | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant | \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Spectrum Dynamics Medical, Ltd. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 22 Bareket St. N. Industrial Park | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Caesarea, 

IL

3079837 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant Contact | Igor Naroditsky | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent | \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Spectrum Dynamics Medical, Ltd. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 22 Bareket St. N. Industrial Park | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Caesarea, 

IL

3079837 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent Contact | Igor Naroditsky | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Regulation Number | 892.2050 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification Product Code | \| QIH \| | QIH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| QIH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Subsequent Product Code | \| LLZ \| | LLZ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| LLZ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Date Received | 11/13/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision Date | 12/30/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision | Substantially Equivalent 

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

| Regulation Medical Specialty | Radiology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510k Review Panel | Radiology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Summary | Summary | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Type | Special | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 \| K253532 \| \| \| \|
\| Device Name \| TruSPECT Processing Station \| \| \| \|
\| Applicant \| \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| \| Spectrum Dynamics Medical, Ltd. \| 22 Bareket St. N. Industrial Park \| Caesarea, 

IL

3079837 \|
\| Spectrum Dynamics Medical, Ltd. \| \| \| \| \|
\| 22 Bareket St. N. Industrial Park \| \| \| \| \|
\| Caesarea, 

IL

3079837 \| \| \| \| \|
\| Applicant Contact \| Igor Naroditsky \| \| \| \|
\| Correspondent \| \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| \| Spectrum Dynamics Medical, Ltd. \| 22 Bareket St. N. Industrial Park \| Caesarea, 

IL

3079837 \|
\| Spectrum Dynamics Medical, Ltd. \| \| \| \| \|
\| 22 Bareket St. N. Industrial Park \| \| \| \| \|
\| Caesarea, 

IL

3079837 \| \| \| \| \|
\| Correspondent Contact \| Igor Naroditsky \| \| \| \|
\| Regulation Number \| 892.2050 \| \| \| \|
\| Classification Product Code \| \| QIH \| \| QIH \| \| \|
\| QIH \| \| \| \| \|
\| Subsequent Product Code \| \| LLZ \| \| LLZ \| \| \|
\| LLZ \| \| \| \| \|
\| Date Received \| 11/13/2025 \| \| \| \|
\| Decision Date \| 12/30/2025 \| \| \| \|
\| Decision \| Substantially Equivalent 

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

\| Regulation Medical Specialty \| Radiology \| \| \| \|
\| 510k Review Panel \| Radiology \| \| \| \|
\| Summary \| Summary \| \| \| \|
\| Type \| Special \| \| \| \|
\| 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 | K253532 | Device Name | TruSPECT Processing Station | Applicant | \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 | Applicant Contact | Igor Naroditsky | Correspondent | \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 | Correspondent Contact | Igor Naroditsky | Regulation Number | 892.2050 | Classification Product Code | \| QIH \| | QIH | Subsequent Product Code | \| LLZ \| | LLZ | Date Received | 11/13/2025 | Decision Date | 12/30/2025 | Decision | Substantially Equivalent 

(SESE) \| Regulation Medical Specialty \| Radiology \| 510k Review Panel \| Radiology \| Summary \| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253532.pdf) \| Type \| Special \| 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 | K253532 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Device Name | TruSPECT Processing Station | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant | \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Spectrum Dynamics Medical, Ltd. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 22 Bareket St. N. Industrial Park | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Caesarea, 

IL

3079837 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant Contact | Igor Naroditsky | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent | \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Spectrum Dynamics Medical, Ltd. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 22 Bareket St. N. Industrial Park | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Caesarea, 

IL

3079837 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent Contact | Igor Naroditsky | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Regulation Number | 892.2050 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification Product Code | \| QIH \| | QIH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| QIH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Subsequent Product Code | \| LLZ \| | LLZ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| LLZ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Date Received | 11/13/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision Date | 12/30/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision | Substantially Equivalent 

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

| Regulation Medical Specialty | Radiology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510k Review Panel | Radiology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Summary | Summary | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Type | Special | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 | K253532 | | | |
| Device Name | TruSPECT Processing Station | | | |
| Applicant | \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 |
| Spectrum Dynamics Medical, Ltd. | | | | |
| 22 Bareket St. N. Industrial Park | | | | |
| Caesarea, 

IL

3079837 | | | | |
| Applicant Contact | Igor Naroditsky | | | |
| Correspondent | \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 |
| Spectrum Dynamics Medical, Ltd. | | | | |
| 22 Bareket St. N. Industrial Park | | | | |
| Caesarea, 

IL

3079837 | | | | |
| Correspondent Contact | Igor Naroditsky | | | |
| Regulation Number | 892.2050 | | | |
| Classification Product Code | \| QIH \| | QIH | | |
| QIH | | | | |
| Subsequent Product Code | \| LLZ \| | LLZ | | |
| LLZ | | | | |
| Date Received | 11/13/2025 | | | |
| Decision Date | 12/30/2025 | | | |
| Decision | Substantially Equivalent 

(SESE) \|  \|  \|  \|

| Regulation Medical Specialty | Radiology | | | |
| 510k Review Panel | Radiology | | | |
| Summary | Summary | | | |
| Type | Special | | | |
| 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 | K253532 | Device Name | TruSPECT Processing Station | Applicant | | Spectrum Dynamics Medical, Ltd. |
| 22 Bareket St. N. Industrial Park |
| Caesarea, 

IL

3079837 | | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 | Applicant Contact | Igor Naroditsky | Correspondent | | Spectrum Dynamics Medical, Ltd. |
| 22 Bareket St. N. Industrial Park |
| Caesarea, 

IL

3079837 | | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 | Correspondent Contact | Igor Naroditsky | Regulation Number | 892.2050 | Classification Product Code | | QIH | | QIH | Subsequent Product Code | | LLZ | | LLZ | Date Received | 11/13/2025 | Decision Date | 12/30/2025 | Decision | Substantially Equivalent 

(SESE) | Regulation Medical Specialty | Radiology | 510k Review Panel | Radiology | Summary | [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253532.pdf) | Type | Special | 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 \| K253532 \| \| \| \|
\| Device Name \| TruSPECT Processing Station \| \| \| \|
\| Applicant \| \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| \| Spectrum Dynamics Medical, Ltd. \| 22 Bareket St. N. Industrial Park \| Caesarea, 

IL

3079837 \|
\| Spectrum Dynamics Medical, Ltd. \| \| \| \| \|
\| 22 Bareket St. N. Industrial Park \| \| \| \| \|
\| Caesarea, 

IL

3079837 \| \| \| \| \|
\| Applicant Contact \| Igor Naroditsky \| \| \| \|
\| Correspondent \| \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| \| Spectrum Dynamics Medical, Ltd. \| 22 Bareket St. N. Industrial Park \| Caesarea, 

IL

3079837 \|
\| Spectrum Dynamics Medical, Ltd. \| \| \| \| \|
\| 22 Bareket St. N. Industrial Park \| \| \| \| \|
\| Caesarea, 

IL

3079837 \| \| \| \| \|
\| Correspondent Contact \| Igor Naroditsky \| \| \| \|
\| Regulation Number \| 892.2050 \| \| \| \|
\| Classification Product Code \| \| QIH \| \| QIH \| \| \|
\| QIH \| \| \| \| \|
\| Subsequent Product Code \| \| LLZ \| \| LLZ \| \| \|
\| LLZ \| \| \| \| \|
\| Date Received \| 11/13/2025 \| \| \| \|
\| Decision Date \| 12/30/2025 \| \| \| \|
\| Decision \| Substantially Equivalent 

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

\| Regulation Medical Specialty \| Radiology \| \| \| \|
\| 510k Review Panel \| Radiology \| \| \| \|
\| Summary \| Summary \| \| \| \|
\| Type \| Special \| \| \| \|
\| 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 | K253532 | Device Name | TruSPECT Processing Station | Applicant | \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 | Applicant Contact | Igor Naroditsky | Correspondent | \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 | Correspondent Contact | Igor Naroditsky | Regulation Number | 892.2050 | Classification Product Code | \| QIH \| | QIH | Subsequent Product Code | \| LLZ \| | LLZ | Date Received | 11/13/2025 | Decision Date | 12/30/2025 | Decision | Substantially Equivalent 

(SESE) \| Regulation Medical Specialty \| Radiology \| 510k Review Panel \| Radiology \| Summary \| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253532.pdf) \| Type \| Special \| 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 | K253532 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Device Name | TruSPECT Processing Station | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant | \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Spectrum Dynamics Medical, Ltd. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 22 Bareket St. N. Industrial Park | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Caesarea, 

IL

3079837 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant Contact | Igor Naroditsky | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent | \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Spectrum Dynamics Medical, Ltd. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 22 Bareket St. N. Industrial Park | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Caesarea, 

IL

3079837 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent Contact | Igor Naroditsky | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Regulation Number | 892.2050 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification Product Code | \| QIH \| | QIH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| QIH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Subsequent Product Code | \| LLZ \| | LLZ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| LLZ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Date Received | 11/13/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision Date | 12/30/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision | Substantially Equivalent 

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

| Regulation Medical Specialty | Radiology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510k Review Panel | Radiology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Summary | Summary | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Type | Special | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 | K253532 | | | |
| Device Name | TruSPECT Processing Station | | | |
| Applicant | \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 |
| Spectrum Dynamics Medical, Ltd. | | | | |
| 22 Bareket St. N. Industrial Park | | | | |
| Caesarea, 

IL

3079837 | | | | |
| Applicant Contact | Igor Naroditsky | | | |
| Correspondent | \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 |
| Spectrum Dynamics Medical, Ltd. | | | | |
| 22 Bareket St. N. Industrial Park | | | | |
| Caesarea, 

IL

3079837 | | | | |
| Correspondent Contact | Igor Naroditsky | | | |
| Regulation Number | 892.2050 | | | |
| Classification Product Code | \| QIH \| | QIH | | |
| QIH | | | | |
| Subsequent Product Code | \| LLZ \| | LLZ | | |
| LLZ | | | | |
| Date Received | 11/13/2025 | | | |
| Decision Date | 12/30/2025 | | | |
| Decision | Substantially Equivalent 

(SESE) \|  \|  \|  \|

| Regulation Medical Specialty | Radiology | | | |
| 510k Review Panel | Radiology | | | |
| Summary | Summary | | | |
| Type | Special | | | |
| 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 | K253532 | Device Name | TruSPECT Processing Station | Applicant | | Spectrum Dynamics Medical, Ltd. |
| 22 Bareket St. N. Industrial Park |
| Caesarea, 

IL

3079837 | | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 | Applicant Contact | Igor Naroditsky | Correspondent | | Spectrum Dynamics Medical, Ltd. |
| 22 Bareket St. N. Industrial Park |
| Caesarea, 

IL

3079837 | | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 | Correspondent Contact | Igor Naroditsky | Regulation Number | 892.2050 | Classification Product Code | | QIH | | QIH | Subsequent Product Code | | LLZ | | LLZ | Date Received | 11/13/2025 | Decision Date | 12/30/2025 | Decision | Substantially Equivalent 

(SESE) | Regulation Medical Specialty | Radiology | 510k Review Panel | Radiology | Summary | [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253532.pdf) | Type | Special | 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 | K253532 | | | |
| Device Name | TruSPECT Processing Station | | | |
| Applicant | \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 |
| Spectrum Dynamics Medical, Ltd. | | | | |
| 22 Bareket St. N. Industrial Park | | | | |
| Caesarea, 

IL

3079837 | | | | |
| Applicant Contact | Igor Naroditsky | | | |
| Correspondent | \| Spectrum Dynamics Medical, Ltd. \|
\| 22 Bareket St. N. Industrial Park \|
\| Caesarea, 

IL

3079837 \| | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 |
| Spectrum Dynamics Medical, Ltd. | | | | |
| 22 Bareket St. N. Industrial Park | | | | |
| Caesarea, 

IL

3079837 | | | | |
| Correspondent Contact | Igor Naroditsky | | | |
| Regulation Number | 892.2050 | | | |
| Classification Product Code | \| QIH \| | QIH | | |
| QIH | | | | |
| Subsequent Product Code | \| LLZ \| | LLZ | | |
| LLZ | | | | |
| Date Received | 11/13/2025 | | | |
| Decision Date | 12/30/2025 | | | |
| Decision | Substantially Equivalent 

(SESE) \|  \|  \|  \|

| Regulation Medical Specialty | Radiology | | | |
| 510k Review Panel | Radiology | | | |
| Summary | Summary | | | |
| Type | Special | | | |
| 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 | K253532 | Device Name | TruSPECT Processing Station | Applicant | | Spectrum Dynamics Medical, Ltd. |
| 22 Bareket St. N. Industrial Park |
| Caesarea, 

IL

3079837 | | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 | Applicant Contact | Igor Naroditsky | Correspondent | | Spectrum Dynamics Medical, Ltd. |
| 22 Bareket St. N. Industrial Park |
| Caesarea, 

IL

3079837 | | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 | Correspondent Contact | Igor Naroditsky | Regulation Number | 892.2050 | Classification Product Code | | QIH | | QIH | Subsequent Product Code | | LLZ | | LLZ | Date Received | 11/13/2025 | Decision Date | 12/30/2025 | Decision | Substantially Equivalent 

(SESE) | Regulation Medical Specialty | Radiology | 510k Review Panel | Radiology | Summary | [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253532.pdf) | Type | Special | 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 | K253532 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Device Name | TruSPECT Processing Station | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant | | Spectrum Dynamics Medical, Ltd. |
| 22 Bareket St. N. Industrial Park |
| Caesarea, 

IL

3079837 | | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Spectrum Dynamics Medical, Ltd. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 22 Bareket St. N. Industrial Park | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Caesarea, 

IL

3079837 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant Contact | Igor Naroditsky | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent | | Spectrum Dynamics Medical, Ltd. |
| 22 Bareket St. N. Industrial Park |
| Caesarea, 

IL

3079837 | | Spectrum Dynamics Medical, Ltd. | 22 Bareket St. N. Industrial Park | Caesarea, 

IL

3079837 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Spectrum Dynamics Medical, Ltd. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 22 Bareket St. N. Industrial Park | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Caesarea, 

IL

3079837 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent Contact | Igor Naroditsky | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Regulation Number | 892.2050 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification Product Code | | QIH | | QIH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| QIH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Subsequent Product Code | | LLZ | | LLZ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| LLZ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Date Received | 11/13/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision Date | 12/30/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision | Substantially Equivalent 

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

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

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

Named provisions

510(k) Premarket Notification

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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
K253532

Who this affects

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

Taxonomy

Primary area
Medical Devices
Operational domain
Compliance
Topics
AI in Healthcare Medical Imaging

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