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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 K133692
Device Name IMRI 1.5T AND IMRI 3T S
Applicant
IMRIS, INC.
5101 Shady Oak Rd
Minnetonka,  MN  55343
Applicant Contact Sanjay Shah
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/02/2013
Decision Date 02/10/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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