# K203517: Saige-Q

- Pathway: 510(k) (Traditional)
- Applicant: DeepHealth, Inc.
- Decided: Apr 16, 2021 after 137 days
- Product code: QFM (Radiological Computer-Assisted Prioritization Software For Lesions)
- Device class: 2
- Regulation: 21 CFR 892.2080
- 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 DEN170073 (2018). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183285: cmTriage, Curemetrix, Inc. (2019) Summary page 4.

## Most influential descendants
- K252954: MammoSightAI (2026), 0 descendants of its own

## Indications for use
Saige-Q is a software workflow tool designed to aid radiologists in prioritizing exams within the standard-of-care image worklist for compatible full-field digital mammography (FFDM) and digital breast tomosynthesis (DBT) screening mammograms. Saige-Q uses an artificial intelligence algorithm to generate a code for a given mammogram, indicative of the software’s suspicion that the mammogram contains at least one suspicious finding. Saige-Q makes the assigned codes available to a PACS/EPR/RIS/workstation for worklist prioritization or triage. Saige-Q is intended for passive notification only and does not provide any diagnostic information beyond triage and prioritization. Thus, it is not intended to replace the review of images or be used on a stand-alone basis for clinical decision-making. The decision to use Saige-Q codes and how to use those codes is ultimately up to the interpreting radiologist. The interpreting radiologist is responsible for reviewing each exam on a diagnostic viewer and evaluating each patient according to the current standard of care.

Source page: https://510kreport.com/device/K203517
Methodology: https://510kreport.com/methodology