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 |