Clearance Summary
Breast BI 7 MR Coil Mammavention 3T received FDA 510(k) clearance under submission number K162651, sponsored by Moras Mri Products GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2017-01-18.
- Submission: K162651
- Applicant / Sponsor: Moras Mri Products GmbH
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2017-01-18
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.