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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 K121449
Device Name DIRECTPATH
Applicant
CYBERNET SYSTEMS CO., LTD.
611 WEST 5TH ST.
AUSTIN,  TX  78701
Applicant Contact DIANE SUDDUTH
Correspondent
CYBERNET SYSTEMS CO., LTD.
611 WEST 5TH ST.
AUSTIN,  TX  78701
Correspondent Contact DIANE SUDDUTH
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/15/2012
Decision Date 07/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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