The following data is part of a premarket notification filed by Imris, Inc. with the FDA for Imrx System V1 And Imrisnv/imriscardio.
| Device ID | K101813 |
| 510k Number | K101813 |
| Device Name: | IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | IMRIS, INC. 16809 BRIARDALE ROAD Rockville, MD 20855 |
| Contact | Thomas M Tsakeris |
| Correspondent | Thomas M Tsakeris IMRIS, INC. 16809 BRIARDALE ROAD Rockville, MD 20855 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-29 |
| Decision Date | 2010-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857534006189 | K101813 | 000 |
| 00857534006172 | K101813 | 000 |
| 00857534006165 | K101813 | 000 |
| 00857534006158 | K101813 | 000 |
| 00857534006141 | K101813 | 000 |
| 00857534006127 | K101813 | 000 |
| 00857534006110 | K101813 | 000 |