# K242295: BunkerHill BMD

- Pathway: 510(k) (Traditional)
- Applicant: BunkerHill Health
- Decided: Apr 8, 2025 after 249 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: 2 generations back to K894854 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

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

## Indications for use
The Bunkerhill BMD Algorithm is a post-processing Al-powered software intended for adults 30 years and above to assess estimated DXA-measured average areal bone mineral density of spinal bones from existing CT scans and outputs a flag for low bone density below a pre-specified threshold. It is not intended to replace DXA or any other tests dedicated to BMD measurement. Bunkerhill BMD 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/K242295
Methodology: https://510kreport.com/methodology