The following data is part of a premarket notification filed by Imris, Inc. with the FDA for Imris Oncology Package.
| Device ID | K121997 |
| 510k Number | K121997 |
| Device Name: | IMRIS ONCOLOGY PACKAGE |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| 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 | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-09 |
| Decision Date | 2012-08-10 |
| Summary: | summary |