K253794
- 510(k) number
- K253794
- Device name
- Prostate Core
- Applicant
- Lucida Medical, Ltd. GB
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-08-10
- Date received
- 2025-11-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K253794.pdf
Official FDA record: K253794
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.