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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name x-ray, tomography, computed, dental
510(k) Number K120753
Device Name CLARISCT
Original Applicant
2580 west 237th street
torrance,  CA  90505
Original Contact greg wachtler
Regulation Number892.1750
Classification Product Code
Date Received03/28/2012
Decision Date 07/26/2012
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