Clearance Summary
MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE received FDA 510(k) clearance under submission number K052704, sponsored by Invivo Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2005-11-03.
- Submission: K052704
- Applicant / Sponsor: Invivo Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2005-11-03
Classification & Regulation
This clearance is catalogued under FDA product code MOS and 21 CFR 892.1000, within the Radiology review panel as a Class II device.