# K243705: Saige-Density (2.5.0)

- Pathway: 510(k) (Special)
- Applicant: DeepHealth, Inc.
- Decided: Dec 19, 2024 after 20 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: 12 generations back to K904519 (1991). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222275: Saige-Density, DeepHealth, Inc. (2022) Summary page 6.

## Indications for use
Saige-Density is a software application intended for use with compatible full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) systems. Saige-Density provides an ACR Bl-RADS Atlas 5th Edition breast density category to aid interpreting physicians in the assessment of breast tissue composition. Saige-Density produces adjunctive information. It is not a diagnostic aid.

Source page: https://510kreport.com/device/K243705
Methodology: https://510kreport.com/methodology