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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
Device Name ICRCO 3600M
Original Applicant
2580 west 237th street
torrance,  CA  90505
Original Contact greg wachtler
Regulation Number892.1715
Classification Product Code
Date Received08/17/2012
Decision Date 04/26/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No