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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 K973959
Device Name OLICON IMAGING SYSTEMS, INC. 02-WORKSTATION AND/OR PACSVIEW SOFTWARE
Applicant
Olicon Imaging Systems, Inc.
6741 Grant Ave.
Plano,  TX  75024
Applicant Contact HERMAN OOSTERWIJCK
Correspondent
Olicon Imaging Systems, Inc.
6741 Grant Ave.
Plano,  TX  75024
Correspondent Contact HERMAN OOSTERWIJCK
Regulation Number892.2020
Classification Product Code
LMD  
Date Received10/16/1997
Decision Date 12/22/1997
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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