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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 K121466
Model V1.0
Device Name GUIDEMIA
Original Applicant
4841 ashbury ave.
cypress,  CA  90630
Original Contact fei gao
Regulation Number892.2050
Classification Product Code
Date Received05/17/2012
Decision Date 05/31/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
statement statement
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No