510(k) K162651
K162651 is an FDA 510(k) premarket notification submitted by Moras Mri Products GmbH for the device "Breast BI 7 MR Coil Mammavention 3T". The FDA issued a decision of Substantially Equivalent on Jan 18, 2017. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 18, 2017
- Date Received
- Sep 23, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coil, Magnetic Resonance, Specialty
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type
- 510(k)