K250831
- 510(k) number
- K250831
- Device name
- Annalise Enterprise
- Applicant
- Annalise-Ai AU
- Product code
- QFM — Radiological Computer-Assisted Prioritization Softwa
- Decision date
- 2025-04-23
- Date received
- 2025-03-19
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250831.pdf
Official FDA record: K250831
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.