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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 K973421
Device Name IMAGESHARE COMPUTED RADIOGRAPHY ACQUISITION STATION AND/OR SOFTWARE(2100{SIKARUS X86}/(1500{WINDOWS NT}
Applicant
DEJARNETTE RESEARCH SYSTEMS
401 WASHINGTON AVE., STE. 1010
TOWSON,  MD  21204
Applicant Contact ERIC J FINEGAN
Correspondent
DEJARNETTE RESEARCH SYSTEMS
401 WASHINGTON AVE., STE. 1010
TOWSON,  MD  21204
Correspondent Contact ERIC J FINEGAN
Regulation Number892.2020
Classification Product Code
LMD  
Date Received09/10/1997
Decision Date 12/05/1997
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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