6 devices · 3 companies · 2021 to 2026
Cosmo Artificial Intelligence - Ai, Ltd.: AI-enabled devices on FDA's list
6 devices from Cosmo Artificial Intelligence - Ai, Ltd., 2021 to 2026, from 3 companies across 1 product code. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (6 of 6 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| GI Genius Module 300K261369 · 510(k) | Gastroenterology-Urology | QNP | database entry | |
| GI Genius Module 100K241887 · 510(k) | Gastroenterology-Urology | QNP | database entry | |
| GI Genius Module 100K233964 · 510(k) | Gastroenterology-Urology | QNP | database entry | |
| GI Genius System 100 and GI Genius System 200K231143 · 510(k) | Gastroenterology-Urology | QNP | database entry | |
| GI GeniusK211951 · 510(k) | Gastroenterology-Urology | QNP | database entry | |
| GI GeniusDEN200055 · De Novo | Gastroenterology-Urology | QNP | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.