FDA-cleared K260166

Bunkerhill Contrast CAC

BunkerHill Health

Detect, localize, and estimate the burden of coronary artery calcification on contrast-enhanced chest CT during clinical care.

Modality
CT/CTA
Anatomy
Chest/coronary arteries
Decision
2026-03-06
FDA-cleared K260167

Bunkerhill Contrast AVC

BunkerHill Health

Detect, localize, and estimate the burden of aortic valve calcification on contrast-enhanced chest CT during clinical care.

Modality
CT/CTA
Anatomy
Chest/aortic valve
Decision
2026-03-06
FDA-cleared K242295

BunkerHill BMD

BunkerHill Health

Analyzes existing CT images in DICOM format from adults aged 30 years and older to estimate average areal BMD of spinal bones and flag low bone density below a preset threshold,...

Modality
CT/CTA
Anatomy
Spine
Decision
2025-04-08
FDA-cleared K240369

CAC (gated) Algorithm

BunkerHill Health

Estimate the presence and quantity of coronary artery calcium in patients aged 30 years and older from non-contrast ECG-gated chest CT, with informational segmentation and...

Modality
CT/CTA
Anatomy
Coronary arteries and coronary artery calcium within the heart
Decision
2024-09-27