The following data is part of a premarket notification filed by Noras Mri Products Gmbh with the FDA for Breast Bi Coil Set 0.55t; Breast Bi 7 Mr Coil Set 1.5t; Breast Bi 7 Mr Coil Set 3t.
| Device ID | K220144 |
| 510k Number | K220144 |
| Device Name: | Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | NORAS MRI Products GmbH Leibnizstrasse 4 Hoechberg, DE 97204 |
| Contact | Manuel Noras |
| Correspondent | Daniel Kamm Kamm & Assosciates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-19 |
| Decision Date | 2022-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251269206962 | K220144 | 000 |
| 04251269206955 | K220144 | 000 |
| 04251269206948 | K220144 | 000 |
| 04251269206764 | K220144 | 000 |
| 04251269206757 | K220144 | 000 |
| 04251269207327 | K220144 | 000 |
| 04251269207334 | K220144 | 000 |
| 04251269207358 | K220144 | 000 |
| 04251269207341 | K220144 | 000 |