Clearance Summary
HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS received FDA 510(k) clearance under submission number K123263, sponsored by Eckert & Ziegler Bebig GmbH. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2013-04-04.
- Submission: K123263
- Applicant / Sponsor: Eckert & Ziegler Bebig GmbH
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 2013-04-04
Classification & Regulation
This clearance is catalogued under FDA product code MUJ and 21 CFR 892.5050, within the Radiology review panel as a Class II device.