The following data is part of a premarket notification filed by Imris, Inc. with the FDA for Visius Wireless Coils, 1.5t/ Visius Wireless Coils, 3t.
| Device ID | K123091 |
| 510k Number | K123091 |
| Device Name: | VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | IMRIS, INC. 100-1370 SONY PLACE Winnipeg, Mb, CA R3t 1n5 |
| Contact | Sanjay Shah |
| Correspondent | Sanjay Shah IMRIS, INC. 100-1370 SONY PLACE Winnipeg, Mb, CA R3t 1n5 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-02 |
| Decision Date | 2012-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857534006387 | K123091 | 000 |
| 10857534006377 | K123091 | 000 |
| 00857534006554 | K123091 | 000 |
| 00857534006547 | K123091 | 000 |