K243853
- 510(k) number
- K243853
- Device name
- Clarius Prostate AI
- Applicant
- Clarius Mobile Health Corp. CA
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2025-04-16
- Date received
- 2024-12-16
- 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: K243853.pdf
Official FDA record: K243853
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.