8 devices · 2 companies · 2024 to 2026
BunkerHill Health: AI-enabled devices on FDA's list
8 devices from BunkerHill Health, 2024 to 2026, from 2 companies across 4 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (8 of 8 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from BunkerHill Health
Panels
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Bunkerhill Contrast CACK260166 · 510(k) | Radiology | JAK | database entry | |
| Bunkerhill Contrast AVCK260167 · 510(k) | Radiology | JAK | database entry | |
| Bunkerhill MACK250662 · 510(k) | Radiology | JAK | database entry | |
| Bunkerhill ECG-EFK250649 · 510(k) | Cardiovascular | QYE | database entry | |
| Bunkerhill Abdominal Aortic QuantificationK243779 · 510(k) | Radiology | QIH | database entry | |
| BunkerHill BMDK242295 · 510(k) | Radiology | KGI | database entry | |
| Bunkerhill AVCK243229 · 510(k) | Radiology | JAK | database entry | |
| CACK240369 · 510(k) | Radiology | JAK | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.