Clearance Summary
PROCEDURE REHEARSAL STUDIO(TM) received FDA 510(k) clearance under submission number K112387, sponsored by Simbionix , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2011-12-27.
- Submission: K112387
- Applicant / Sponsor: Simbionix , Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2011-12-27
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.