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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K963592
Device Name IMAGESHARE PROTOCOL CONVERTING GATEWAY AND/OR SOFTWARE [OS/2 WARP] 1OOO,[SUN/SOLARIS] 2000
Applicant
DEJARNETTE RESEARCH SYSTEMS
401 WASHINGTON AVE.
STE 700
TOWSON,  MD  21204
Applicant Contact WAYNE T DEJARNETTE, PH.D.
Correspondent
DEJARNETTE RESEARCH SYSTEMS
401 WASHINGTON AVE.
STE 700
TOWSON,  MD  21204
Correspondent Contact WAYNE T DEJARNETTE, PH.D.
Regulation Number892.2020
Classification Product Code
LMD  
Date Received09/09/1996
Decision Date 11/07/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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