K251964
- 510(k) number
- K251964
- Device name
- Mimics Thoracic Planner
- Applicant
- Materialise NV BE
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2026-03-12
- Date received
- 2025-06-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.0 MB · U.S. public domain
Also available from FDA: K251964.pdf
Official FDA record: K251964
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.