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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
Device Name GUIDEMIA
Original Applicant
GUIDEMIA TECHNOLOGIES, LLC
4841 ashbury ave.
cypress,  CA  90630
Original Contact fei gao
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/17/2012
Decision Date 05/31/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
statement statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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