K233964 is an FDA 510(k) clearance for the GI Genius™ Module 100 (GGM100.US). This device is classified as a Gastrointesinal Lesion Software Detection System (Class II - Special Controls, product code QNP).
Submitted by Cosmo Artificial Intelligence - Ai, Ltd. (Dublin, IE). The FDA issued a Cleared decision on January 12, 2024, 28 days after receiving the submission on December 15, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1520. A Gastrointestinal Lesion Software Detection System Is A Computer-assisted Detection Device Used In Conjunction With Endoscopy For The Detection Of Abnormal Lesions In The Gastrointestinal Tract. This Device With Advanced Software Algorithms Brings Attention To Images To Aid In The Detection Of Lesions. The Device May Contain Hardware To Support Interfacing With An Endoscope..
| 510(k) Number | K233964 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2023 |
| Decision Date | January 12, 2024 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | QNP - Gastrointesinal Lesion Software Detection System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1520 |
| Definition | A Gastrointestinal Lesion Software Detection System Is A Computer-assisted Detection Device Used In Conjunction With Endoscopy For The Detection Of Abnormal Lesions In The Gastrointestinal Tract. This Device With Advanced Software Algorithms Brings Attention To Images To Aid In The Detection Of Lesions. The Device May Contain Hardware To Support Interfacing With An Endoscope. |