K223427
- 510(k) number
- K223427
- Device name
- Mimics Enlight CMF
- Applicant
- Materialise NV BE
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2024-05-31
- Date received
- 2022-11-14
- 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: K223427.pdf
Official FDA record: K223427
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.