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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K123091
Device Name VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T
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
MOS  
Date Received10/02/2012
Decision Date 12/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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