CAC (gated) Algorithm
BunkerHill Health
BUNKERHILL HEALTH
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3027245002 | 3027245002 | BUNKERHILL HEALTH | 1 | N | 2026-01-01 | 144 2nd St Ste 100 San Francisco CA US 94105 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 316893 | 1531612438 | K260167 | Bunkerhill Contrast AVC | JAK | 2026-03-06 |
| 316893 | 1829966444 | K250649 | Bunkerhill ECG-EF | QYE | 2025-09-19 |
| 316893 | 1720228764 | K243779 | Bunkerhill Abdominal Aortic Quantification (AAQ) | QIH | 2025-07-01 |
| 316893 | 1430980611 | K242295 | BunkerHill BMD | KGI | 2025-04-08 |
| 316893 | 1207179766 | K240369 | CAC (gated) Algorithm | JAK | 2024-09-27 |
| 316893 | 1278331985 | K230223 | iCAC Device | JAK | 2023-04-25 |