# K254131: BAC

- Pathway: 510(k) (Traditional)
- Applicant: DeepHealth, Inc.
- Decided: May 21, 2026 after 150 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: 1 generation back to K250754 (2025). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250754: cmAngio® (V1.6), Curemetrix, Inc. (2025) Summary page 6.

## Indications for use
BAC is intended to process screening mammograms to aid a qualified interpreting physician in the current manual process of identifying breast arterial calcifications. BAC, a proprietary artificial intelligence (AI) based software device, is intended to detect, at the study and breast level, the presence or absence of breast arterial calcifications, an incidental finding in both Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms. The device also provides localization information of detected breast arterial calcification on images. The software device is intended to be used by qualified interpreting physicians in parallel with breast screening mammography workflow. The device is not intended for primary interpretation of digital mammography images as used for breast cancer detection. It should not be used alone to make any diagnosis and/or treatment decisions.

Source page: https://510kreport.com/device/K254131
Methodology: https://510kreport.com/methodology