3 devices · 2 companies · 2018 to 2026
Athelas, Inc.: AI-enabled devices on FDA's list
3 devices from Athelas, Inc., 2018 to 2026, from 2 companies across 1 product code. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 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 |
|---|---|---|---|---|
| Athelas HomeK243348 · 510(k) | Hematology | GKZ | database entry | |
| Athelas HomeK200828 · 510(k) | Hematology | GKZ | database entry | |
| Athelas OneK181288 · 510(k) | Hematology | GKZ | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.