Clearance Summary
CT Sim Laser System received FDA 510(k) clearance under submission number K152303, sponsored by Gammex, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2015-09-11.
- Submission: K152303
- Applicant / Sponsor: Gammex, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.5780
- Decision date: 2015-09-11
Classification & Regulation
This clearance is catalogued under FDA product code IWE and 21 CFR 892.5780, within the Radiology review panel as a Class I device.