K253122 is an FDA 510(k) clearance for the Sim&Size. This device is classified as a Software For Visualization Of Vascular Anatomy And Intravascular Devices (Class II - Special Controls, product code PZO).
Submitted by Sim&Cure (Montpellier, FR). The FDA issued a Cleared decision on December 23, 2025, 89 days after receiving the submission on September 25, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 892.2050. Visualization And Measurement Of Blood Vessels And Intravascular Devices For Preoperational Planning..
| 510(k) Number | K253122 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2025 |
| Decision Date | December 23, 2025 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | PZO - Software For Visualization Of Vascular Anatomy And Intravascular Devices |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |
| Definition | Visualization And Measurement Of Blood Vessels And Intravascular Devices For Preoperational Planning. |