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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 K081752
Device Name EDGE PACS
Applicant
ASHVA TECHNOLOGIES, PVT. LTD
1600 MANCHESTER WAY
CORINTH,  TX  76210
Applicant Contact CARL ALLETTO
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/20/2008
Decision Date 08/06/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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