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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K955092
Device Name ACCURAD IMAGE MANAGEMENT SYSTEM, AUTORAD, REGUSTRATION STATION, ARCHIVE SERVER, PRINT SPOOLER, ANALOG & DIGITAL ACQUIRE
Applicant
Cemax-Icon, Inc.
47281 Mission Falls Ct.
Fremont,  CA  94539
Applicant Contact LINDA J MOORE
Correspondent
Cemax-Icon, Inc.
47281 Mission Falls Ct.
Fremont,  CA  94539
Correspondent Contact LINDA J MOORE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/07/1995
Decision Date 05/09/1996
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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