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FDA-cleared K252029

AI-CVD

HeartLung Corporation

Authorized purpose: AI-CVD provides automated quantitative CT-derived anatomical and density measurements for clinician review, including calcium scores, cardiac and vascular measurements, lung and liver density, bone mineral density, and muscle/fat composition; it is opportunistic decision support, not diagnostic interpretation or risk prediction.

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

ABMD Software

HeartLung Corporation

Authorized purpose: 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- and sex-referenced Z and T scores.

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