K252571
- 510(k) number
- K252571
- Device name
- mdprostate
- Applicant
- Mediaire GmbH DE
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-08-07
- Date received
- 2025-08-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252571.pdf
Official FDA record: K252571
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.