K252954
- 510(k) number
- K252954
- Device name
- MammoSightAI
- Applicant
- Neurocareai, Inc. (Dba Savelife.Ai) TX · US
- Product code
- QFM — Radiological Computer-Assisted Prioritization Softwa
- Decision date
- 2026-05-04
- Date received
- 2025-09-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K252954.pdf
Official FDA record: K252954
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.