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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 K121023
Device Name SPECTRUM V.0
Original Applicant
INTRINSIC MEDICAL IMAGING
2550 south telegraph rd
ste 108
bloomfield hills,  MI  48304
Original Contact stephen j goldner, jd, rac
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/04/2012
Decision Date 05/31/2012
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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