Radiology AI Directory

Vendor

HeartLung Corporation

2 FDA-cleared listings in this directory.

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FDA-cleared K252029

AI-CVD

HeartLung Corporation

AI-CVD provides automated quantitative CT-derived anatomical and density measurements for clinician review, including calcium scores, cardiac and vascular measurements, lung and...

Modality
CT/CTA
Anatomy
Chest, abdomen, heart, lungs, liver, aorta, pulmonary artery, bone, muscle, and fat
Decision
2025-12-19
Cardiac imagingMSK and boneOncology quantification
FDA-cleared K213760

ABMD Software

HeartLung Corporation

The Automated Bone Mineral Density Software Module measures bone mineral density from existing CT by averaging Hounsfield units in trabecular vertebral bone and can calculate age-...

Modality
CT/CTA
Anatomy
Trabecular vertebral bone and lumbar spine
Decision
2022-07-29
MSK and boneQuantification and segmentation