DEN200055 is an FDA 510(k) submission for the GI Genius. 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 Not Cleared (DENG) decision on April 9, 2021.
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 | DEN200055 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | September 08, 2020 |
| Decision Date | April 09, 2021 |
| Days to Decision | 213 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | - |
| 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. |