6 devices · 1 company · 2019 to 2026
AliveCor, Inc.: AI-enabled devices on FDA's list
6 devices from AliveCor, Inc., 2019 to 2026, from 1 company across 3 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (5 of 6 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from AliveCor, Inc.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Corvair MonzaK252589 · 510(k) | Cardiovascular | MHX | database entry | |
| ImpalaK232035 · 510(k) | Cardiovascular | DPS | database entry | |
| CorvairK231010 · 510(k) | Cardiovascular | MHX | database entry | |
| AliveCor QT ServiceK212662 · 510(k) | Cardiovascular | DQK | database entry | |
| KardiaAIK201985 · 510(k) | Cardiovascular | DQK | database entry | |
| KardiaAIK181823 · 510(k) | Cardiovascular | DQK | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.