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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 K082964
Device Name PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5)
Applicant
PRISM CLINICAL IMAGING, INC.
851 S. 70TH ST., SUITE 103
WEST ALLIS,  WI  53214
Applicant Contact JAMES L REUSS
Correspondent
PRISM CLINICAL IMAGING, INC.
851 S. 70TH ST., SUITE 103
WEST ALLIS,  WI  53214
Correspondent Contact JAMES L REUSS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received10/03/2008
Decision Date 03/09/2009
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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