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FDA SKOUT system K253664 Medical Device Notification

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Summary

The FDA has published a 510(k) premarket notification for the SKOUT system (K253664). This notification indicates a new medical device has been cleared for market. Further details on the device's specific function and intended use are available through the provided FDA database link.

Published by FDA on accessdata.fda.gov . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .
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What changed

This document is a 510(k) premarket notification from the FDA for the SKOUT system, identified by K253664. A 510(k) is a process by which the FDA determines if a new medical device is substantially equivalent to a legally marketed device. This notification signifies that the SKOUT system has met the FDA's clearance requirements for market entry.

For compliance officers, this notification serves as an informational update regarding a new medical device entering the market. While it does not impose new direct obligations, it is relevant for understanding the evolving landscape of medical devices, particularly those that may incorporate AI or advanced technologies. Companies involved in the medical device sector should be aware of such clearances as they may impact competitive analysis or supply chain considerations. No immediate action is required based solely on this notification.

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Mar 23, 2026

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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 \| Gastrointesinal Lesion Software Detection System \| \| \| \| \|
\| --- \| --- \| \| \| \| \|
\| 510(k) Number \| K253664 \| \| \| \| \|
\| Device Name \| SKOUT system \| \| \| \| \|
\| Applicant \| \\| Iterative Health \\|
\\| 14 Arrow St., Floor 3 \\|
\\| Cambridge, 
MA 
02138 \\| \| Iterative Health \| 14 Arrow St., Floor 3 \| Cambridge, 
MA 
02138 \| \|
\| Iterative Health \| \| \| \| \| \|
\| 14 Arrow St., Floor 3 \| \| \| \| \| \|
\| Cambridge, 
MA 
02138 \| \| \| \| \| \|
\| Applicant Contact \| Caitlyn Seidl \| \| \| \| \|
\| Correspondent \| \\| Hogan Lovells US LLP \\|
\\| 1735 Market St. \\|
\\| Floor 23 \\|
\\| Philadelphia, 
PA 
19103 \\| \| Hogan Lovells US LLP \| 1735 Market St. \| Floor 23 \| Philadelphia, 
PA 
19103 \|
\| Hogan Lovells US LLP \| \| \| \| \| \|
\| 1735 Market St. \| \| \| \| \| \|
\| Floor 23 \| \| \| \| \| \|
\| Philadelphia, 
PA 
19103 \| \| \| \| \| \|
\| Correspondent Contact \| Janice Hogan \| \| \| \| \|
\| Regulation Number \| 876.1520 \| \| \| \| \|
\| Classification Product Code \| \\| QNP \\| \| QNP \| \| \| \|
\| QNP \| \| \| \| \| \|
\| Date Received \| 11/20/2025 \| \| \| \| \|
\| Decision Date \| 12/22/2025 \| \| \| \| \|
\| Decision \| Substantially Equivalent 

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

\| Regulation Medical Specialty \| Gastroenterology/Urology \| \| \| \| \|
\| 510k Review Panel \| Gastroenterology/Urology \| \| \| \| \|
\| Summary \| Summary \| \| \| \| \|
\| Type \| Special \| \| \| \| \|
\| Reviewed by Third Party \| No \| \| \| \| \|
\| Combination Product \| No \| \| \| \| \|
\| Predetermined Change
Control Plan Authorized \| No \| \| \| \| \| \| Device Classification Name \| Gastrointesinal Lesion Software Detection System \| 510(k) Number \| K253664 \| Device Name \| SKOUT system \| Applicant \| \| Iterative Health \|
\| 14 Arrow St., Floor 3 \|
\| Cambridge, 
MA 
02138 \| \| Iterative Health \| 14 Arrow St., Floor 3 \| Cambridge, 
MA 
02138 \| Applicant Contact \| Caitlyn Seidl \| Correspondent \| \| Hogan Lovells US LLP \|
\| 1735 Market St. \|
\| Floor 23 \|
\| Philadelphia, 
PA 
19103 \| \| Hogan Lovells US LLP \| 1735 Market St. \| Floor 23 \| Philadelphia, 
PA 
19103 \| Correspondent Contact \| Janice Hogan \| Regulation Number \| 876.1520 \| Classification Product Code \| \| QNP \| \| QNP \| Date Received \| 11/20/2025 \| Decision Date \| 12/22/2025 \| Decision \| Substantially Equivalent 

(SESE) \\| Regulation Medical Specialty \\| Gastroenterology/Urology \\| 510k Review Panel \\| Gastroenterology/Urology \\| Summary \\| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253664.pdf) \\| Type \\| Special \\| Reviewed by Third Party \\| No \\| Combination Product \\| No \\| Predetermined Change

Control Plan Authorized \| No \|
\| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \| --- \|
\| Device Classification Name \| Gastrointesinal Lesion Software Detection System \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| 510(k) Number \| K253664 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Device Name \| SKOUT system \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Applicant \| \| Iterative Health \|
\| 14 Arrow St., Floor 3 \|
\| Cambridge, 
MA 
02138 \| \| Iterative Health \| 14 Arrow St., Floor 3 \| Cambridge, 
MA 
02138 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Iterative Health \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| 14 Arrow St., Floor 3 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Cambridge, 
MA 
02138 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Applicant Contact \| Caitlyn Seidl \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Correspondent \| \| Hogan Lovells US LLP \|
\| 1735 Market St. \|
\| Floor 23 \|
\| Philadelphia, 
PA 
19103 \| \| Hogan Lovells US LLP \| 1735 Market St. \| Floor 23 \| Philadelphia, 
PA 
19103 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Hogan Lovells US LLP \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| 1735 Market St. \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Floor 23 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Philadelphia, 
PA 
19103 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Correspondent Contact \| Janice Hogan \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Regulation Number \| 876.1520 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Classification Product Code \| \| QNP \| \| QNP \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| QNP \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Date Received \| 11/20/2025 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Decision Date \| 12/22/2025 \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Decision \| Substantially Equivalent 

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

\| Regulation Medical Specialty \| Gastroenterology/Urology \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| 510k Review Panel \| Gastroenterology/Urology \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Summary \| Summary \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Type \| Special \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Reviewed by Third Party \| No \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Combination Product \| No \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \|
\| Predetermined Change
Control Plan Authorized \| No \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| \| | \| Device Classification Name \| Gastrointesinal Lesion Software Detection System \| \| \| \| \|
\| --- \| --- \| \| \| \| \|
\| 510(k) Number \| K253664 \| \| \| \| \|
\| Device Name \| SKOUT system \| \| \| \| \|
\| Applicant \| \| Iterative Health \|
\| 14 Arrow St., Floor 3 \|
\| Cambridge, 
MA 
02138 \| \| Iterative Health \| 14 Arrow St., Floor 3 \| Cambridge, 
MA 
02138 \| \|
\| Iterative Health \| \| \| \| \| \|
\| 14 Arrow St., Floor 3 \| \| \| \| \| \|
\| Cambridge, 
MA 
02138 \| \| \| \| \| \|
\| Applicant Contact \| Caitlyn Seidl \| \| \| \| \|
\| Correspondent \| \| Hogan Lovells US LLP \|
\| 1735 Market St. \|
\| Floor 23 \|
\| Philadelphia, 
PA 
19103 \| \| Hogan Lovells US LLP \| 1735 Market St. \| Floor 23 \| Philadelphia, 
PA 
19103 \|
\| Hogan Lovells US LLP \| \| \| \| \| \|
\| 1735 Market St. \| \| \| \| \| \|
\| Floor 23 \| \| \| \| \| \|
\| Philadelphia, 
PA 
19103 \| \| \| \| \| \|
\| Correspondent Contact \| Janice Hogan \| \| \| \| \|
\| Regulation Number \| 876.1520 \| \| \| \| \|
\| Classification Product Code \| \| QNP \| \| QNP \| \| \| \|
\| QNP \| \| \| \| \| \|
\| Date Received \| 11/20/2025 \| \| \| \| \|
\| Decision Date \| 12/22/2025 \| \| \| \| \|
\| Decision \| Substantially Equivalent 

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

\| Regulation Medical Specialty \| Gastroenterology/Urology \| \| \| \| \|
\| 510k Review Panel \| Gastroenterology/Urology \| \| \| \| \|
\| Summary \| Summary \| \| \| \| \|
\| Type \| Special \| \| \| \| \|
\| Reviewed by Third Party \| No \| \| \| \| \|
\| Combination Product \| No \| \| \| \| \|
\| Predetermined Change
Control Plan Authorized \| No \| \| \| \| \| | Device Classification Name | Gastrointesinal Lesion Software Detection System | 510(k) Number | K253664 | Device Name | SKOUT system | Applicant | \| Iterative Health \|
\| 14 Arrow St., Floor 3 \|
\| Cambridge, 
MA 
02138 \| | Iterative Health | 14 Arrow St., Floor 3 | Cambridge, 
MA 
02138 | Applicant Contact | Caitlyn Seidl | Correspondent | \| Hogan Lovells US LLP \|
\| 1735 Market St. \|
\| Floor 23 \|
\| Philadelphia, 
PA 
19103 \| | Hogan Lovells US LLP | 1735 Market St. | Floor 23 | Philadelphia, 
PA 
19103 | Correspondent Contact | Janice Hogan | Regulation Number | 876.1520 | Classification Product Code | \| QNP \| | QNP | Date Received | 11/20/2025 | Decision Date | 12/22/2025 | Decision | Substantially Equivalent 

(SESE) \| Regulation Medical Specialty \| Gastroenterology/Urology \| 510k Review Panel \| Gastroenterology/Urology \| Summary \| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253664.pdf) \| Type \| Special \| Reviewed by Third Party \| No \| Combination Product \| No \| Predetermined Change

Control Plan Authorized | No |
| \| Device Classification Name \| Gastrointesinal Lesion Software Detection System \| \| \| \| \|
\| --- \| --- \| \| \| \| \|
\| 510(k) Number \| K253664 \| \| \| \| \|
\| Device Name \| SKOUT system \| \| \| \| \|
\| Applicant \| \| Iterative Health \|
\| 14 Arrow St., Floor 3 \|
\| Cambridge, 
MA 
02138 \| \| Iterative Health \| 14 Arrow St., Floor 3 \| Cambridge, 
MA 
02138 \| \|
\| Iterative Health \| \| \| \| \| \|
\| 14 Arrow St., Floor 3 \| \| \| \| \| \|
\| Cambridge, 
MA 
02138 \| \| \| \| \| \|
\| Applicant Contact \| Caitlyn Seidl \| \| \| \| \|
\| Correspondent \| \| Hogan Lovells US LLP \|
\| 1735 Market St. \|
\| Floor 23 \|
\| Philadelphia, 
PA 
19103 \| \| Hogan Lovells US LLP \| 1735 Market St. \| Floor 23 \| Philadelphia, 
PA 
19103 \|
\| Hogan Lovells US LLP \| \| \| \| \| \|
\| 1735 Market St. \| \| \| \| \| \|
\| Floor 23 \| \| \| \| \| \|
\| Philadelphia, 
PA 
19103 \| \| \| \| \| \|
\| Correspondent Contact \| Janice Hogan \| \| \| \| \|
\| Regulation Number \| 876.1520 \| \| \| \| \|
\| Classification Product Code \| \| QNP \| \| QNP \| \| \| \|
\| QNP \| \| \| \| \| \|
\| Date Received \| 11/20/2025 \| \| \| \| \|
\| Decision Date \| 12/22/2025 \| \| \| \| \|
\| Decision \| Substantially Equivalent 

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

\| Regulation Medical Specialty \| Gastroenterology/Urology \| \| \| \| \|
\| 510k Review Panel \| Gastroenterology/Urology \| \| \| \| \|
\| Summary \| Summary \| \| \| \| \|
\| Type \| Special \| \| \| \| \|
\| Reviewed by Third Party \| No \| \| \| \| \|
\| Combination Product \| No \| \| \| \| \|
\| Predetermined Change
Control Plan Authorized \| No \| \| \| \| \| | Device Classification Name | Gastrointesinal Lesion Software Detection System | 510(k) Number | K253664 | Device Name | SKOUT system | Applicant | \| Iterative Health \|
\| 14 Arrow St., Floor 3 \|
\| Cambridge, 
MA 
02138 \| | Iterative Health | 14 Arrow St., Floor 3 | Cambridge, 
MA 
02138 | Applicant Contact | Caitlyn Seidl | Correspondent | \| Hogan Lovells US LLP \|
\| 1735 Market St. \|
\| Floor 23 \|
\| Philadelphia, 
PA 
19103 \| | Hogan Lovells US LLP | 1735 Market St. | Floor 23 | Philadelphia, 
PA 
19103 | Correspondent Contact | Janice Hogan | Regulation Number | 876.1520 | Classification Product Code | \| QNP \| | QNP | Date Received | 11/20/2025 | Decision Date | 12/22/2025 | Decision | Substantially Equivalent 

(SESE) \| Regulation Medical Specialty \| Gastroenterology/Urology \| 510k Review Panel \| Gastroenterology/Urology \| Summary \| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253664.pdf) \| Type \| Special \| Reviewed by Third Party \| No \| Combination Product \| No \| Predetermined Change

Control Plan Authorized | No | |
| Device Classification Name | Gastrointesinal Lesion Software Detection System | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510(k) Number | K253664 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Device Name | SKOUT system | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant | \| Iterative Health \|
\| 14 Arrow St., Floor 3 \|
\| Cambridge, 
MA 
02138 \| | Iterative Health | 14 Arrow St., Floor 3 | Cambridge, 
MA 
02138 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Iterative Health | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 14 Arrow St., Floor 3 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cambridge, 
MA 
02138 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant Contact | Caitlyn Seidl | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent | \| Hogan Lovells US LLP \|
\| 1735 Market St. \|
\| Floor 23 \|
\| Philadelphia, 
PA 
19103 \| | Hogan Lovells US LLP | 1735 Market St. | Floor 23 | Philadelphia, 
PA 
19103 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Hogan Lovells US LLP | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 1735 Market St. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Floor 23 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Philadelphia, 
PA 
19103 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent Contact | Janice Hogan | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Regulation Number | 876.1520 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification Product Code | \| QNP \| | QNP | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| QNP | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Date Received | 11/20/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision Date | 12/22/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision | Substantially Equivalent 

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

| Regulation Medical Specialty | Gastroenterology/Urology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510k Review Panel | Gastroenterology/Urology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 \| Gastrointesinal Lesion Software Detection System \| \| \| \| \|
\| --- \| --- \| \| \| \| \|
\| 510(k) Number \| K253664 \| \| \| \| \|
\| Device Name \| SKOUT system \| \| \| \| \|
\| Applicant \| \| Iterative Health \|
\| 14 Arrow St., Floor 3 \|
\| Cambridge, 
MA 
02138 \| \| Iterative Health \| 14 Arrow St., Floor 3 \| Cambridge, 
MA 
02138 \| \|
\| Iterative Health \| \| \| \| \| \|
\| 14 Arrow St., Floor 3 \| \| \| \| \| \|
\| Cambridge, 
MA 
02138 \| \| \| \| \| \|
\| Applicant Contact \| Caitlyn Seidl \| \| \| \| \|
\| Correspondent \| \| Hogan Lovells US LLP \|
\| 1735 Market St. \|
\| Floor 23 \|
\| Philadelphia, 
PA 
19103 \| \| Hogan Lovells US LLP \| 1735 Market St. \| Floor 23 \| Philadelphia, 
PA 
19103 \|
\| Hogan Lovells US LLP \| \| \| \| \| \|
\| 1735 Market St. \| \| \| \| \| \|
\| Floor 23 \| \| \| \| \| \|
\| Philadelphia, 
PA 
19103 \| \| \| \| \| \|
\| Correspondent Contact \| Janice Hogan \| \| \| \| \|
\| Regulation Number \| 876.1520 \| \| \| \| \|
\| Classification Product Code \| \| QNP \| \| QNP \| \| \| \|
\| QNP \| \| \| \| \| \|
\| Date Received \| 11/20/2025 \| \| \| \| \|
\| Decision Date \| 12/22/2025 \| \| \| \| \|
\| Decision \| Substantially Equivalent 

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

\| Regulation Medical Specialty \| Gastroenterology/Urology \| \| \| \| \|
\| 510k Review Panel \| Gastroenterology/Urology \| \| \| \| \|
\| Summary \| Summary \| \| \| \| \|
\| Type \| Special \| \| \| \| \|
\| Reviewed by Third Party \| No \| \| \| \| \|
\| Combination Product \| No \| \| \| \| \|
\| Predetermined Change
Control Plan Authorized \| No \| \| \| \| \| | Device Classification Name | Gastrointesinal Lesion Software Detection System | 510(k) Number | K253664 | Device Name | SKOUT system | Applicant | \| Iterative Health \|
\| 14 Arrow St., Floor 3 \|
\| Cambridge, 
MA 
02138 \| | Iterative Health | 14 Arrow St., Floor 3 | Cambridge, 
MA 
02138 | Applicant Contact | Caitlyn Seidl | Correspondent | \| Hogan Lovells US LLP \|
\| 1735 Market St. \|
\| Floor 23 \|
\| Philadelphia, 
PA 
19103 \| | Hogan Lovells US LLP | 1735 Market St. | Floor 23 | Philadelphia, 
PA 
19103 | Correspondent Contact | Janice Hogan | Regulation Number | 876.1520 | Classification Product Code | \| QNP \| | QNP | Date Received | 11/20/2025 | Decision Date | 12/22/2025 | Decision | Substantially Equivalent 

(SESE) \| Regulation Medical Specialty \| Gastroenterology/Urology \| 510k Review Panel \| Gastroenterology/Urology \| Summary \| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253664.pdf) \| Type \| Special \| Reviewed by Third Party \| No \| Combination Product \| No \| Predetermined Change

Control Plan Authorized | No |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Device Classification Name | Gastrointesinal Lesion Software Detection System | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510(k) Number | K253664 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Device Name | SKOUT system | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant | \| Iterative Health \|
\| 14 Arrow St., Floor 3 \|
\| Cambridge, 
MA 
02138 \| | Iterative Health | 14 Arrow St., Floor 3 | Cambridge, 
MA 
02138 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Iterative Health | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 14 Arrow St., Floor 3 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cambridge, 
MA 
02138 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant Contact | Caitlyn Seidl | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent | \| Hogan Lovells US LLP \|
\| 1735 Market St. \|
\| Floor 23 \|
\| Philadelphia, 
PA 
19103 \| | Hogan Lovells US LLP | 1735 Market St. | Floor 23 | Philadelphia, 
PA 
19103 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Hogan Lovells US LLP | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 1735 Market St. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Floor 23 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Philadelphia, 
PA 
19103 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent Contact | Janice Hogan | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Regulation Number | 876.1520 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification Product Code | \| QNP \| | QNP | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| QNP | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Date Received | 11/20/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision Date | 12/22/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision | Substantially Equivalent 

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

| Regulation Medical Specialty | Gastroenterology/Urology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510k Review Panel | Gastroenterology/Urology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Summary | Summary | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Type | Special | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Reviewed by Third Party | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Combination Product | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Predetermined Change
Control Plan Authorized | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Device Classification Name | Gastrointesinal Lesion Software Detection System | | | | |
| --- | --- | | | | |
| 510(k) Number | K253664 | | | | |
| Device Name | SKOUT system | | | | |
| Applicant | \| Iterative Health \|
\| 14 Arrow St., Floor 3 \|
\| Cambridge, 
MA 
02138 \| | Iterative Health | 14 Arrow St., Floor 3 | Cambridge, 
MA 
02138 | |
| Iterative Health | | | | | |
| 14 Arrow St., Floor 3 | | | | | |
| Cambridge, 
MA 
02138 | | | | | |
| Applicant Contact | Caitlyn Seidl | | | | |
| Correspondent | \| Hogan Lovells US LLP \|
\| 1735 Market St. \|
\| Floor 23 \|
\| Philadelphia, 
PA 
19103 \| | Hogan Lovells US LLP | 1735 Market St. | Floor 23 | Philadelphia, 
PA 
19103 |
| Hogan Lovells US LLP | | | | | |
| 1735 Market St. | | | | | |
| Floor 23 | | | | | |
| Philadelphia, 
PA 
19103 | | | | | |
| Correspondent Contact | Janice Hogan | | | | |
| Regulation Number | 876.1520 | | | | |
| Classification Product Code | \| QNP \| | QNP | | | |
| QNP | | | | | |
| Date Received | 11/20/2025 | | | | |
| Decision Date | 12/22/2025 | | | | |
| Decision | Substantially Equivalent 

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

| Regulation Medical Specialty | Gastroenterology/Urology | | | | |
| 510k Review Panel | Gastroenterology/Urology | | | | |
| Summary | Summary | | | | |
| Type | Special | | | | |
| Reviewed by Third Party | No | | | | |
| Combination Product | No | | | | |
| Predetermined Change
Control Plan Authorized | No | | | | | | Device Classification Name | Gastrointesinal Lesion Software Detection System | 510(k) Number | K253664 | Device Name | SKOUT system | Applicant | | Iterative Health |
| 14 Arrow St., Floor 3 |
| Cambridge, 
MA 
02138 | | Iterative Health | 14 Arrow St., Floor 3 | Cambridge, 
MA 
02138 | Applicant Contact | Caitlyn Seidl | Correspondent | | Hogan Lovells US LLP |
| 1735 Market St. |
| Floor 23 |
| Philadelphia, 
PA 
19103 | | Hogan Lovells US LLP | 1735 Market St. | Floor 23 | Philadelphia, 
PA 
19103 | Correspondent Contact | Janice Hogan | Regulation Number | 876.1520 | Classification Product Code | | QNP | | QNP | Date Received | 11/20/2025 | Decision Date | 12/22/2025 | Decision | Substantially Equivalent 

(SESE) | Regulation Medical Specialty | Gastroenterology/Urology | 510k Review Panel | Gastroenterology/Urology | Summary | [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253664.pdf) | Type | Special | Reviewed by Third Party | No | Combination Product | No | Predetermined Change
Control Plan Authorized No
\ New Search \
New Search Back To Search Results
\ \
\ --- \
\ 510(k) Number \
\ Device Name \
\ Applicant \
\\ 14 Arrow St., Floor 3 \\
\\ Cambridge,  
MA 
02138 \\\| \\| Iterative Health \\| 14 Arrow St., Floor 3 \\| Cambridge, 
MA 
02138 \\|  \\|

\| Iterative Health \| \| \| \| \| \|
\| 14 Arrow St., Floor 3 \| \| \| \| \| \|
\| Cambridge, 
MA 
02138 \| \| \| \| \| \|
\| Applicant Contact \| Caitlyn Seidl \| \| \| \| \|
\| Correspondent \| \| Hogan Lovells US LLP \|
\| 1735 Market St. \|
\| Floor 23 \|
\| Philadelphia, 
PA 
19103 \| \| Hogan Lovells US LLP \| 1735 Market St. \| Floor 23 \| Philadelphia, 
PA 
19103 \|
\| Hogan Lovells US LLP \| \| \| \| \| \|
\| 1735 Market St. \| \| \| \| \| \|
\| Floor 23 \| \| \| \| \| \|
\| Philadelphia, 
PA 
19103 \| \| \| \| \| \|
\| Correspondent Contact \| Janice Hogan \| \| \| \| \|
\| Regulation Number \| 876.1520 \| \| \| \| \|
\| Classification Product Code \| \| QNP \| \| QNP \| \| \| \|
\| QNP \| \| \| \| \| \|
\| Date Received \| 11/20/2025 \| \| \| \| \|
\| Decision Date \| 12/22/2025 \| \| \| \| \|
\| Decision \| Substantially Equivalent 

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

\| Regulation Medical Specialty \| Gastroenterology/Urology \| \| \| \| \|
\| 510k Review Panel \| Gastroenterology/Urology \| \| \| \| \|
\| Summary \| Summary \| \| \| \| \|
\| Type \| Special \| \| \| \| \|
\| Reviewed by Third Party \| No \| \| \| \| \|
\| Combination Product \| No \| \| \| \| \|
\| Predetermined Change
Control Plan Authorized \| No \| \| \| \| \| | Device Classification Name | Gastrointesinal Lesion Software Detection System | 510(k) Number | K253664 | Device Name | SKOUT system | Applicant | \| Iterative Health \|
\| 14 Arrow St., Floor 3 \|
\| Cambridge, 
MA 
02138 \| | Iterative Health | 14 Arrow St., Floor 3 | Cambridge, 
MA 
02138 | Applicant Contact | Caitlyn Seidl | Correspondent | \| Hogan Lovells US LLP \|
\| 1735 Market St. \|
\| Floor 23 \|
\| Philadelphia, 
PA 
19103 \| | Hogan Lovells US LLP | 1735 Market St. | Floor 23 | Philadelphia, 
PA 
19103 | Correspondent Contact | Janice Hogan | Regulation Number | 876.1520 | Classification Product Code | \| QNP \| | QNP | Date Received | 11/20/2025 | Decision Date | 12/22/2025 | Decision | Substantially Equivalent 

(SESE) \| Regulation Medical Specialty \| Gastroenterology/Urology \| 510k Review Panel \| Gastroenterology/Urology \| Summary \| [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253664.pdf) \| Type \| Special \| Reviewed by Third Party \| No \| Combination Product \| No \| Predetermined Change

Control Plan Authorized | No |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Device Classification Name | Gastrointesinal Lesion Software Detection System | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510(k) Number | K253664 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Device Name | SKOUT system | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant | \| Iterative Health \|
\| 14 Arrow St., Floor 3 \|
\| Cambridge, 
MA 
02138 \| | Iterative Health | 14 Arrow St., Floor 3 | Cambridge, 
MA 
02138 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Iterative Health | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 14 Arrow St., Floor 3 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cambridge, 
MA 
02138 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant Contact | Caitlyn Seidl | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent | \| Hogan Lovells US LLP \|
\| 1735 Market St. \|
\| Floor 23 \|
\| Philadelphia, 
PA 
19103 \| | Hogan Lovells US LLP | 1735 Market St. | Floor 23 | Philadelphia, 
PA 
19103 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Hogan Lovells US LLP | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 1735 Market St. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Floor 23 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Philadelphia, 
PA 
19103 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent Contact | Janice Hogan | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Regulation Number | 876.1520 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification Product Code | \| QNP \| | QNP | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| QNP | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Date Received | 11/20/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision Date | 12/22/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision | Substantially Equivalent 

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

| Regulation Medical Specialty | Gastroenterology/Urology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510k Review Panel | Gastroenterology/Urology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Summary | Summary | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Type | Special | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Reviewed by Third Party | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Combination Product | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Predetermined Change
Control Plan Authorized | No | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Device Classification Name | Gastrointesinal Lesion Software Detection System | | | | |
| --- | --- | | | | |
| 510(k) Number | K253664 | | | | |
| Device Name | SKOUT system | | | | |
| Applicant | \| Iterative Health \|
\| 14 Arrow St., Floor 3 \|
\| Cambridge, 
MA 
02138 \| | Iterative Health | 14 Arrow St., Floor 3 | Cambridge, 
MA 
02138 | |
| Iterative Health | | | | | |
| 14 Arrow St., Floor 3 | | | | | |
| Cambridge, 
MA 
02138 | | | | | |
| Applicant Contact | Caitlyn Seidl | | | | |
| Correspondent | \| Hogan Lovells US LLP \|
\| 1735 Market St. \|
\| Floor 23 \|
\| Philadelphia, 
PA 
19103 \| | Hogan Lovells US LLP | 1735 Market St. | Floor 23 | Philadelphia, 
PA 
19103 |
| Hogan Lovells US LLP | | | | | |
| 1735 Market St. | | | | | |
| Floor 23 | | | | | |
| Philadelphia, 
PA 
19103 | | | | | |
| Correspondent Contact | Janice Hogan | | | | |
| Regulation Number | 876.1520 | | | | |
| Classification Product Code | \| QNP \| | QNP | | | |
| QNP | | | | | |
| Date Received | 11/20/2025 | | | | |
| Decision Date | 12/22/2025 | | | | |
| Decision | Substantially Equivalent 

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

| Regulation Medical Specialty | Gastroenterology/Urology | | | | |
| 510k Review Panel | Gastroenterology/Urology | | | | |
| Summary | Summary | | | | |
| Type | Special | | | | |
| Reviewed by Third Party | No | | | | |
| Combination Product | No | | | | |
| Predetermined Change
Control Plan Authorized | No | | | | | | Device Classification Name | Gastrointesinal Lesion Software Detection System | 510(k) Number | K253664 | Device Name | SKOUT system | Applicant | | Iterative Health |
| 14 Arrow St., Floor 3 |
| Cambridge, 
MA 
02138 | | Iterative Health | 14 Arrow St., Floor 3 | Cambridge, 
MA 
02138 | Applicant Contact | Caitlyn Seidl | Correspondent | | Hogan Lovells US LLP |
| 1735 Market St. |
| Floor 23 |
| Philadelphia, 
PA 
19103 | | Hogan Lovells US LLP | 1735 Market St. | Floor 23 | Philadelphia, 
PA 
19103 | Correspondent Contact | Janice Hogan | Regulation Number | 876.1520 | Classification Product Code | | QNP | | QNP | Date Received | 11/20/2025 | Decision Date | 12/22/2025 | Decision | Substantially Equivalent 

(SESE) | Regulation Medical Specialty | Gastroenterology/Urology | 510k Review Panel | Gastroenterology/Urology | Summary | [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253664.pdf) | Type | Special | Reviewed by Third Party | No | Combination Product | No | Predetermined Change

Control Plan Authorized | No | | | | |
| | Device Classification Name | Gastrointesinal Lesion Software Detection System | | | | |
| --- | --- | | | | |
| 510(k) Number | K253664 | | | | |
| Device Name | SKOUT system | | | | |
| Applicant | \| Iterative Health \|
\| 14 Arrow St., Floor 3 \|
\| Cambridge, 
MA 
02138 \| | Iterative Health | 14 Arrow St., Floor 3 | Cambridge, 
MA 
02138 | |
| Iterative Health | | | | | |
| 14 Arrow St., Floor 3 | | | | | |
| Cambridge, 
MA 
02138 | | | | | |
| Applicant Contact | Caitlyn Seidl | | | | |
| Correspondent | \| Hogan Lovells US LLP \|
\| 1735 Market St. \|
\| Floor 23 \|
\| Philadelphia, 
PA 
19103 \| | Hogan Lovells US LLP | 1735 Market St. | Floor 23 | Philadelphia, 
PA 
19103 |
| Hogan Lovells US LLP | | | | | |
| 1735 Market St. | | | | | |
| Floor 23 | | | | | |
| Philadelphia, 
PA 
19103 | | | | | |
| Correspondent Contact | Janice Hogan | | | | |
| Regulation Number | 876.1520 | | | | |
| Classification Product Code | \| QNP \| | QNP | | | |
| QNP | | | | | |
| Date Received | 11/20/2025 | | | | |
| Decision Date | 12/22/2025 | | | | |
| Decision | Substantially Equivalent 

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

| Regulation Medical Specialty | Gastroenterology/Urology | | | | |
| 510k Review Panel | Gastroenterology/Urology | | | | |
| Summary | Summary | | | | |
| Type | Special | | | | |
| Reviewed by Third Party | No | | | | |
| Combination Product | No | | | | |
| Predetermined Change
Control Plan Authorized | No | | | | | | Device Classification Name | Gastrointesinal Lesion Software Detection System | 510(k) Number | K253664 | Device Name | SKOUT system | Applicant | | Iterative Health |
| 14 Arrow St., Floor 3 |
| Cambridge, 
MA 
02138 | | Iterative Health | 14 Arrow St., Floor 3 | Cambridge, 
MA 
02138 | Applicant Contact | Caitlyn Seidl | Correspondent | | Hogan Lovells US LLP |
| 1735 Market St. |
| Floor 23 |
| Philadelphia, 
PA 
19103 | | Hogan Lovells US LLP | 1735 Market St. | Floor 23 | Philadelphia, 
PA 
19103 | Correspondent Contact | Janice Hogan | Regulation Number | 876.1520 | Classification Product Code | | QNP | | QNP | Date Received | 11/20/2025 | Decision Date | 12/22/2025 | Decision | Substantially Equivalent 

(SESE) | Regulation Medical Specialty | Gastroenterology/Urology | 510k Review Panel | Gastroenterology/Urology | Summary | [Summary](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253664.pdf) | Type | Special | Reviewed by Third Party | No | Combination Product | No | Predetermined Change

Control Plan Authorized | No | | | | | |
| Device Classification Name | Gastrointesinal Lesion Software Detection System | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510(k) Number | K253664 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Device Name | SKOUT system | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant | | Iterative Health |
| 14 Arrow St., Floor 3 |
| Cambridge, 
MA 
02138 | | Iterative Health | 14 Arrow St., Floor 3 | Cambridge, 
MA 
02138 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Iterative Health | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 14 Arrow St., Floor 3 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Cambridge, 
MA 
02138 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Applicant Contact | Caitlyn Seidl | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent | | Hogan Lovells US LLP |
| 1735 Market St. |
| Floor 23 |
| Philadelphia, 
PA 
19103 | | Hogan Lovells US LLP | 1735 Market St. | Floor 23 | Philadelphia, 
PA 
19103 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Hogan Lovells US LLP | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 1735 Market St. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Floor 23 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Philadelphia, 
PA 
19103 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Correspondent Contact | Janice Hogan | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Regulation Number | 876.1520 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification Product Code | | QNP | | QNP | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| QNP | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Date Received | 11/20/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision Date | 12/22/2025 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Decision | Substantially Equivalent 

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

| Regulation Medical Specialty | Gastroenterology/Urology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 510k Review Panel | Gastroenterology/Urology | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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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FDA AI-Enabled Medical Devices fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices
Healthcare & Life Sciences

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Classification

Agency
FDA
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
K253664

Who this affects

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

Taxonomy

Primary area
Medical Devices
Operational domain
Compliance
Topics
Artificial Intelligence Healthcare Technology

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