2 devices · 1 company · 2019 to 2020
VivaQuant Inc.: AI-enabled devices on FDA's list
2 devices from VivaQuant Inc., 2019 to 2020, from 1 company across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 2 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from VivaQuant Inc.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| RX-1 Rhythm Express Remote Cardiac Monitoring SyK200833 · 510(k) | Cardiovascular | MLO | database entry | |
| RX-1 Rhythm Express Remote Cardiac Monitoring SyK183704 · 510(k) | Cardiovascular | DXH | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.