The following data is part of a premarket notification filed by Qfix with the FDA for Encompass 15 Channel Head Coil, 3t.
| Device ID | K190668 |
| 510k Number | K190668 |
| Device Name: | Encompass 15 Channel Head Coil, 3T |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | Qfix 440 Church Road Avondale, PA 19311 |
| Contact | Alexandra Low Smythe |
| Correspondent | Alexandra Low Smythe Qfix 440 Church Road Avondale, PA 19311 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-15 |
| Decision Date | 2019-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251269204722 | K190668 | 000 |
| 04251269204708 | K190668 | 000 |
| 04251269204685 | K190668 | 000 |
| 04251269204494 | K190668 | 000 |
| 04251269204487 | K190668 | 000 |
| 04251269204470 | K190668 | 000 |
| 04251269207273 | K190668 | 000 |