6 devices · 1 company · 2018 to 2026
iRhythm Technologies, Inc.: AI-enabled devices on FDA's list
6 devices from iRhythm Technologies, Inc., 2018 to 2026, 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 (6 of 6 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 |
|---|---|---|---|---|
| ZEUS PlatformK252859 · 510(k) | Cardiovascular | DQK | database entry | |
| ZEUS SystemK222389 · 510(k) | Cardiovascular | DQK | database entry | |
| ZEUS SystemK213409 · 510(k) | Cardiovascular | DQK | database entry | |
| Zio ECG Utilization SoftwareK202527 · 510(k) | Cardiovascular | DQK | database entry | |
| Zio XT ECG Monitoring System, Zio AT ECG MonitorK190593 · 510(k) | Cardiovascular | DQK | database entry | |
| Zio AT ECG Monitoring System, ZEUS SystemK181502 · 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.