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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K121447
Device Name ISCHEMA VIEW RAPID
Original Applicant
ISCHEMA VIEW, INC.
5405 alton parkway 5a, #530
irvine,  CA  92604
Original Contact marc goodman
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/15/2012
Decision Date 10/04/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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