6 devices · 5 companies · 2016 to 2026
AI-enabled general hospital devices on FDA's list
6 devices in the General Hospital panel, 2016 to 2026, from 5 companies across 3 product codes. 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.
Product codes in the General Hospital panel
Companies with more than one device here
Every device, newest decision first
| Decision | Device | Company | Product code | FDA |
|---|---|---|---|---|
| Bayesian Health Sepsis Flagging DeviceK250680 · 510(k) | Bayesian Health, Inc. | SAK | database entry | |
| SurgiCount+ SystemK252282 · 510(k) | Stryker Instruments | PBZ | database entry | |
| Sepsis ImmunoScoreDEN230036 · De Novo | Prenosis, Inc. | SAK | database entry | |
| SurgiCount+ SystemK232250 · 510(k) | Stryker Instruments | PBZ | database entry | |
| WellDoc BlueStarK190013 · 510(k) | WellDoc, Inc. | MRZ | database entry | |
| Triton SystemK160338 · 510(k) | GAUSS SURGICAL INC. | PBZ | database entry |
Every panel in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.