K251474
- 510(k) number
- K251474
- Device name
- Median LCS (internal name) / eyonis LCS (trade name) (1.0)
- Applicant
- Median Technologies FR
- Product code
- QDQ — Radiological Computer Assisted Detection/Diagnosis S
- Decision date
- 2026-02-06
- Date received
- 2025-05-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K251474.pdf
Official FDA record: K251474
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.