K180123 is an FDA 510(k) clearance for the Breast BI 7 MR Coil 1.5T Mammavention. This device is classified as a Coil, Magnetic Resonance, Specialty (Class II - Special Controls, product code MOS).
Submitted by Noras Mri Products GmbH (Hoechberg, DE). The FDA issued a Cleared decision on February 16, 2018, 31 days after receiving the submission on January 16, 2018.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K180123 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 2018 |
| Decision Date | February 16, 2018 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MOS - Coil, Magnetic Resonance, Specialty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1000 |