# K243688: Saige-Dx (3.1.0)

- Pathway: 510(k) (Special)
- Applicant: DeepHealth, Inc.
- Decided: Dec 19, 2024 after 20 days
- Product code: QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer)
- Device class: 2
- Regulation: 21 CFR 892.2090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN180005 (2018). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241747: Saige-Dx, DeepHealth, Inc. (2024) Summary page 6.

## Most influential descendants
- K251873: Saige-Dx (2025), 1 descendant of its own
- K253825: Saige-Dx (2026), 0 descendants of its own

## Indications for use
Saige-Dx analyzes digital breast tomosynthesis (DBT) mammograms to identify the presence or absence of soft tissue lesions and calcifications that may be indicative of cancer. For a given DBT mammogram, Saige-Dx analyzes the DBT image stacks and the accompanying 2D images, including full field digital mammography and/or synthetic images. The system assigns a Suspicion Level, indicating the strength of suspicion that cancer may be present, for each detected finding and for the entire case. The outputs of Saige-Dx are intended to be used as a concurrent reading aid for interpreting physicians on screening mammograms with compatible DBT hardware.

Source page: https://510kreport.com/device/K243688
Methodology: https://510kreport.com/methodology