The following data is part of a premarket notification filed by Noras Mri Products Gmbh with the FDA for Breast Bi 7 Mr Coil 1.5t Mammavention.
| Device ID | K180123 |
| 510k Number | K180123 |
| Device Name: | Breast BI 7 MR Coil 1.5T Mammavention |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | Noras MRI Products GmbH Leibnizstrasse 4 Hoechberg, DE 97204 |
| Contact | Jens Heidenmann |
| Correspondent | Jens Heidenmann Noras MRI Products GmbH Leibnizstrasse 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 | 2018-01-16 |
| Decision Date | 2018-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251269205583 | K180123 | 000 |
| 04251269205941 | K180123 | 000 |
| 04251269205965 | K180123 | 000 |
| 04251269206979 | K180123 | 000 |