K243069
- 510(k) number
- K243069
- Device name
- LUMYS (V1)
- Applicant
- Intradys FR
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-05-02
- Date received
- 2024-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243069.pdf
Official FDA record: K243069
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.