2 devices · 1 company · 2021 to 2022
Digital Diagnostics Inc.: AI-enabled devices on FDA's list
2 devices from Digital Diagnostics 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 2 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 |
|---|---|---|---|---|
| IDx-DR v2.3K213037 · 510(k) | Ophthalmic | PIB | database entry | |
| IDx-DRK203629 · 510(k) | Ophthalmic | PIB | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.