K242124
- 510(k) number
- K242124
- Device name
- Sim&Size
- Applicant
- Sim&Cure FR
- Product code
- PZO — Software For Visualization Of Vascular Anatomy And I
- Decision date
- 2024-12-14
- Date received
- 2024-07-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K242124.pdf
Official FDA record: K242124
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.