7 devices · 2 companies · 2020 to 2024
Avicenna.AI: AI-enabled devices on FDA's list
7 devices from Avicenna.AI, 2020 to 2024, from 2 companies across 3 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (7 of 7 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Avicenna.AI
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| CINA-CSpineK240942 · 510(k) | Radiology | QAS | database entry | |
| CINA-VCFK240612 · 510(k) | Radiology | QFM | database entry | |
| CINA-ASPECTSK233342 · 510(k) | Radiology | POK | database entry | |
| CINA-iPEK233968 · 510(k) | Radiology | QAS | database entry | |
| CINAK221716 · 510(k) | Radiology | QAS | database entry | |
| CINA CHESTK210237 · 510(k) | Radiology | QAS | database entry | |
| CINAK200855 · 510(k) | Radiology | QAS | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.