3 devices · 1 company · 2021 to 2022
Fifth Eye Inc.: AI-enabled devices on FDA's list
3 devices from Fifth Eye Inc., 2021 to 2022, from 1 company across 1 product code. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 3 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 |
|---|---|---|---|---|
| AHI SystemK221203 · 510(k) | Cardiovascular | QNV | database entry | |
| AHI SystemK212219 · 510(k) | Cardiovascular | QNV | database entry | |
| Analytic for Hemodynamic InstabilityDEN200022 · De Novo | Cardiovascular | QNV | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.