# K213760: ABMD Software

- Pathway: 510(k) (Traditional)
- Applicant: HeartLung Corporation
- Decided: Jul 29, 2022 after 240 days
- Product code: KGI (Densitometer, Bone)
- Device class: 2
- Regulation: 21 CFR 892.1170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K894854 (1989). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894854: QCT Bone Mineral Density Analysis Software, Image Enhancements (1989) Summary page 4.

## Most influential descendants
- K252029: AI-CVD (2025), 0 descendants of its own
- K242295: BunkerHill BMD (2025), 0 descendants of its own

## Indications for use
The Automated Bone Mineral Density Software Module (ABMD) is a post-processing Al-powered software intended to measure bone mineral density (BMD) from existing CT scans by averaging Hounsfield units in the trabecular region of vertebral bones. ABMD is not intended to replace DXA or any other tests dedicated to BMD measurement. It is solely designed for measuring BMD in existing CT scans or CT scans ordered for reasons other than BMD measurement. In summary, ABMD is an opportunistic Al-powered tool that enables: (1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans, and (3) assessment of bone density without a phantom as an independent measurement procedure.

Source page: https://510kreport.com/device/K213760
Methodology: https://510kreport.com/methodology