Clearance Summary
HDR IORT SHIELDED APPLICATOR received FDA 510(k) clearance under submission number K052351, 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 2005-10-17.
- Submission: K052351
- Applicant / Sponsor: Mick Radio-Nuclear Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5700
- Decision date: 2005-10-17
Classification & Regulation
This clearance is catalogued under FDA product code JAQ and 21 CFR 892.5700, within the Radiology review panel as a Class II device.