K252482
- 510(k) number
- K252482
- Device name
- CogNet AI-MT+
- Applicant
- Medcognetics, Inc. TX · US
- Product code
- QFM — Radiological Computer-Assisted Prioritization Softwa
- Decision date
- 2025-12-11
- Date received
- 2025-08-07
- 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: K252482.pdf
Official FDA record: K252482
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.