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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
Applicant
MEDDIFF TECHNOLOGIES PVT. LTD
1600 MANCHESTER WAY
CORINTH,  TX  76210
Applicant Contact CARL ALLETTO
Correspondent
MEDDIFF TECHNOLOGIES PVT. LTD
1600 MANCHESTER WAY
CORINTH,  TX  76210
Correspondent Contact CARL ALLETTO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/08/2012
Decision Date 04/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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