Clearance Summary
BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC received FDA 510(k) clearance under submission number K052987, sponsored by Noras Rontgen-Und Medizintechnik GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2005-11-08.
- Submission: K052987
- Applicant / Sponsor: Noras Rontgen-Und Medizintechnik GmbH
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2005-11-08
Classification & Regulation
This clearance is catalogued under FDA product code LNH and 21 CFR 892.1000, within the Radiology review panel as a Class II device.