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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 K120718
Device Name INSTAPACS/INSTARISPACS
Original Applicant
MEDDIFF TECHNOLOGIES PVT. LTD
1600 manchester way
corinth,  TX  76210
Original Contact carl alletto
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/08/2012
Decision Date 04/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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