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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K121997
Device Name IMRIS ONCOLOGY PACKAGE
Applicant
IMRIS, INC.
100-1370 SONY PLACE
WINNIPEG, MB,  CA R3T 1N5
Applicant Contact Sanjay Shah
Correspondent
IMRIS, INC.
100-1370 SONY PLACE
WINNIPEG, MB,  CA R3T 1N5
Correspondent Contact Sanjay Shah
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
MOS  
Date Received07/09/2012
Decision Date 08/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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