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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name full field digital,system,x-ray,mammographic
510(k) Number K122510
Model 3600M
Device Name ICRCO 3600M
Original Applicant
ICRCO INC.
2580 west 237th street
torrance,  CA  90505
Original Contact greg wachtler
Regulation Number892.1715
Classification Product Code
MUE  
Date Received08/17/2012
Decision Date 04/26/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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