Clearance Summary
DISPOSABLE SHADOW TRAY INSERTS received FDA 510(k) clearance under submission number K871215, sponsored by Mick Radio-Nuclear Instruments, 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 1987-04-06.
- Submission: K871215
- Applicant / Sponsor: Mick Radio-Nuclear Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5750
- Decision date: 1987-04-06
Classification & Regulation
This clearance is catalogued under FDA product code IWB and 21 CFR 892.5750, within the Radiology review panel as a Class II device.