The following data is part of a premarket notification filed by Rapid Biomedical Gmbh with the FDA for 1.5t 16ch Diagnostic Breast Coil, 3.0t 16ch Diagnostic Breast Coil.
| Device ID | K181948 |
| 510k Number | K181948 |
| Device Name: | 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | RAPID Biomedical GmbH Kettelerstr. 3-11 Rimpar, DE 97222 |
| Contact | Christian Zimmermann |
| Correspondent | Christian Zimmermann RAPID Biomedical GmbH Kettelerstr. 3-11 Rimpar, DE 97222 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-20 |
| Decision Date | 2018-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260487680225 | K181948 | 000 |
| 04260487680218 | K181948 | 000 |
| 04260487680201 | K181948 | 000 |
| 04260487680195 | K181948 | 000 |
| 04260487680188 | K181948 | 000 |
| 04260487680171 | K181948 | 000 |
| 04260487680102 | K181948 | 000 |
| 04260487680096 | K181948 | 000 |