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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Angiographic
510(k) Number K925961
Device Name OPTIMA ARCHIVAL AND RETRIEVAL SYSTEM
Applicant
Diagnostic Archives, Inc.
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Diagnostic Archives, Inc.
Columbia Sq.
555 Thirteenth St., NW
Washington, D.C.,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number892.1600
Classification Product Code
IZI  
Date Received11/25/1992
Decision Date 03/02/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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