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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Digital Image Storage, Radiological
510(k) Number K973463
Device Name OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE
Applicant
O Tech, Inc.
6741 Grant Ln.
Plano,  TX  75024
Applicant Contact HERMAN OOSTERWIJCK
Correspondent
O Tech, Inc.
6741 Grant Ln.
Plano,  TX  75024
Correspondent Contact HERMAN OOSTERWIJCK
Regulation Number892.2010
Classification Product Code
LMB  
Date Received09/12/1997
Decision Date 12/02/1997
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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