The following data is part of a premarket notification filed by Imris, Inc. with the FDA for Imri 1.5t And Imri 3t S.
| Device ID | K133692 |
| 510k Number | K133692 |
| Device Name: | IMRI 1.5T AND IMRI 3T S |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | IMRIS, INC. 5101 Shady Oak Rd Minnetonka, MN 55343 |
| Contact | Sanjay Shah |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-12-02 |
| Decision Date | 2014-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857534006103 | K133692 | 000 |
| 00857534006097 | K133692 | 000 |
| 00857534006080 | K133692 | 000 |
| 00857534006073 | K133692 | 000 |
| 00857534006066 | K133692 | 000 |
| 00857534006059 | K133692 | 000 |
| 00857534006042 | K133692 | 000 |
| 00857534006035 | K133692 | 000 |