Clearance Summary
INTEGRATED BRACHYTHERAPY UNIT - DIGITAL received FDA 510(k) clearance under submission number K072445, sponsored by Nucletron Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2007-09-14.
- Submission: K072445
- Applicant / Sponsor: Nucletron Corp.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5840
- Decision date: 2007-09-14
Classification & Regulation
This clearance is catalogued under FDA product code KPQ and 21 CFR 892.5840, within the Radiology review panel as a Class II device.