K253122
- 510(k) number
- K253122
- Device name
- Sim&Size
- Applicant
- Sim&Cure FR
- Product code
- PZO — Software For Visualization Of Vascular Anatomy And I
- Decision date
- 2025-12-23
- Date received
- 2025-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K253122.pdf
Official FDA record: K253122
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.