# K252029: AI-CVD

- Pathway: 510(k) (Traditional)
- Applicant: HeartLung Corporation
- Decided: Dec 19, 2025 after 172 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K913770 (1991). 76 ancestors in all.
No later device cites it as a predicate yet.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240786: AutoChamber, HeartLung Corporation (2024) Summary page 5.
- K213760: ABMD Software, HeartLung Corporation (2022) Summary page 5.

## Indications for use
AI-CVD® is an opportunistic AI-powered quantitative imaging tool that provides automated CT-derived anatomical and density-based measurements for clinician review. The device does not provide diagnostic interpretation or risk prediction. It is solely intended to aid physicians and other healthcare providers in determining whether additional diagnostic tests are appropriate for implementing preventive healthcare plans. AI-CVD® has a modular structure where each module is intended to report quantitative imaging measurements for each specific component of the CT scan. AI-CVD® quantitative imaging measurement modules include coronary artery calcium (CAC) score, aortic wall calcium score, aortic valve calcium score, mitral valve calcium score, cardiac chambers volumetry, epicardial fat volumetry, aorta and pulmonary artery sizing, lung density, liver density, bone mineral density, and muscle & fat composition. Using AI-CVD® quantitative imaging measurements and their clinical evaluation, healthcare providers can investigate patients who are unaware of their risk of coronary heart disease, heart failure, atrial fibrillation, stroke, osteoporosis, liver steatosis, diabetes, and other adverse health conditions that may warrant additional risk assessment, monitoring or follow-up. AI-CVD® quantitative imaging measurements are to be reviewed by radiologists or other medical professionals and should only be used by healthcare providers in conjunction with clinical evaluation. AI-CVD® is not intended to rule out the risk of cardiovascular diseases. AI-CVD® opportunistic screening software can be applied to non-contrast thoracic CT scans such as those obtained for CAC scans, lung cancer screening scans, and other chest diagnostic CT scans. Similarly, AI-CVD® opportunistic screening software can be applied to contrast-enhanced CT scans such as coronary CT angiography (CCTA) and CT pulmonary angiography (CTPA) scans. AI-CVD® opportunistic bone density module and liver density module can be applied to CT scans of the abdomen and pelvis. All volumetric quantitative imaging measurements from the AI-CVD® opportunistic screening software are adjusted by body surface area (BSA) and reported both in cubic centimeter volume (cc) and percentiles by gender reference data from people who participated in the Multi-Ethnic Study of Atherosclerosis (MESA) and Framingham Heart Study (FHS). Except for coronary artery calcium scoring, other AI-CVD® modules should not be ordered as a standalone CT scan but instead should be used as an opportunistic add-on to existing and new CT scans.

Source page: https://510kreport.com/device/K252029
Methodology: https://510kreport.com/methodology