FDA-cleared K240369
CAC (gated) Algorithm
BunkerHill Health
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-09-27
Vendor
BunkerHill Health
5 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K243229
Bunkerhill AVC
BunkerHill Health
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-01-27
FDA-cleared K242295
BunkerHill BMD
BunkerHill Health
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-04-08
FDA-cleared K243779
Bunkerhill Abdominal Aortic Quantification (AAQ)
BunkerHill Health
Image analysis/processing for Cardiovascular using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Cardiovascular
- Decision
- 2025-07-01
FDA-cleared K250662
Bunkerhill MAC
Bunkerhill Health
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2025-10-03