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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 K963594
Device Name IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION)
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
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