Clearance Summary
Sim&Size received FDA 510(k) clearance under submission number K253122, sponsored by Sim&Cure. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2025-12-23.
- Submission: K253122
- Applicant / Sponsor: Sim&Cure
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2025-12-23
Classification & Regulation
This clearance is catalogued under FDA product code PZO and 21 CFR 892.2050, within the Radiology review panel as a Class II device.