GI Genius
Gastrointesinal Lesion Software Detection System
Cosmo Artificial Intelligence - AI Ltd
The following data is part of a premarket notification filed by Cosmo Artificial Intelligence - Ai Ltd with the FDA for Gi Genius.
Pre-market Notification Details
| Device ID | K211951 |
| 510k Number | K211951 |
| Device Name: | GI Genius |
| Classification | Gastrointesinal Lesion Software Detection System |
| Applicant | Cosmo Artificial Intelligence - AI Ltd Riverside II, Sir John Rogerson’s Quay Dublin, IE D02 Kv60 |
| Contact | Nhan Ngo Dinh |
| Correspondent | Roger Gray Donawa Lifescience Consluting Srl Piazza Albania 10 Rome, IT 00153 |
| Product Code | QNP |
| CFR Regulation Number | 876.1520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-23 |
| Decision Date | 2021-07-23 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521807259 | K211951 | 000 |
Trademark Results [GI Genius]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GI GENIUS 88431147 not registered Live/Pending |
Covidien LP 2019-05-15 |
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