BunkerHill Health - FDA 510(k) Cleared Devices
Recent clearances: Bunkerhill Contrast CAC, Bunkerhill Contrast AVC, Bunkerhill MAC
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - BunkerHill Health Radiology ✕
7 devices
Cleared
Mar 06, 2026
Bunkerhill Contrast CAC
Radiology
45d
Cleared
Mar 06, 2026
Bunkerhill Contrast AVC
Radiology
45d
Cleared
Oct 03, 2025
Bunkerhill MAC
Radiology
212d
Cleared
Jul 01, 2025
Bunkerhill Abdominal Aortic Quantification (AAQ)
Radiology
204d
Cleared
Apr 08, 2025
BunkerHill BMD
Radiology
249d
Cleared
Jan 27, 2025
Bunkerhill AVC
Radiology
111d
Cleared
Sep 27, 2024
CAC (gated) Algorithm
Radiology
233d