The following data is part of a premarket notification filed by Moras Mri Products Gmbh with the FDA for Breast Bi 7 Mr Coil Mammavention 3t.
| Device ID | K162651 |
| 510k Number | K162651 |
| Device Name: | Breast BI 7 MR Coil Mammavention 3T |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | MORAS MRI Products GmbH Leibnizstr. 4 Hoechberg, DE 97204 |
| Contact | Zahed Sedighiani |
| Correspondent | Zahed Sedighiani MORAS MRI Products GmbH Leibnizstr. 4 Hoechberg, DE 97204 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-23 |
| Decision Date | 2017-01-18 |
| Summary: | summary |