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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 K945428
Device Name SCRIBE(TM) DIAGNOSTIC IMAGING WORKSTATION
Applicant
Multi-Dimensional Imaging, Inc.
450 Newport Center Dr.
Suite 200
Newport Beach,  CA  92660
Applicant Contact HARVEY EISENBERG
Correspondent
Multi-Dimensional Imaging, Inc.
450 Newport Center Dr.
Suite 200
Newport Beach,  CA  92660
Correspondent Contact HARVEY EISENBERG
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/04/1994
Decision Date 03/09/1995
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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