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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
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