# K252954: MammoSightAI

- Pathway: 510(k) (Traditional)
- Applicant: Neurocareai, Inc. (Dba Savelife.Ai)
- Decided: May 4, 2026 after 230 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: 3 generations back to DEN170073 (2018). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203517: Saige-Q, DeepHealth, Inc. (2021) Summary page 5.

## Indications for use
MammoSightAI is a software radiological workflow tool designed to assist radiologists in prioritizing exams within the standard-of-care image worklist for compatible FFDM and DBT screening mammograms. Utilizing an advanced artificial intelligence algorithm, MammoSightAI analyzes each mammogram and assigns a tag indicating the software’s suspicion of at least one potentially suspicious finding. These assigned tags are seamlessly integrated into the hospital PACS or workstation, enabling worklist prioritization or triage to help radiologists focus on the most critical cases first. MammoSightAI 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 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/K252954
Methodology: https://510kreport.com/methodology