# K251078: AutoDensity

- Pathway: 510(k) (Traditional)
- Applicant: Eos Imaging
- Decided: Nov 14, 2025 after 220 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: 16 generations back to K904519 (1991). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251747: VEA Align; spineEOS, Eos Imaging (2025). Cleared while this submission was under review Summary page 6.

## Indications for use
AutoDensity is a post-processing software intended to estimate spine Bone Mineral Density (BMD) from EOSedge dual energy images for orthopedic pre-surgical assessment applications. It is an opportunistic tool that enables immediate assessment of bone density from EOSedge images acquired for other purposes. AutoDensity is not intended to replace DXA screening. Suspected low BMD should be confirmed by a DXA exam. Clinical judgment and experience are required to properly use the software.

Source page: https://510kreport.com/device/K251078
Methodology: https://510kreport.com/methodology