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 |