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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K933493
Device Name RAM-PACS
Applicant
Medical Knowledge Systems, Inc.
3800 Woodward Ave.
Suite 900
Detroit,  MI  48201
Applicant Contact SCOTT TAYLOR
Correspondent
Medical Knowledge Systems, Inc.
3800 Woodward Ave.
Suite 900
Detroit,  MI  48201
Correspondent Contact SCOTT TAYLOR
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/19/1993
Decision Date 11/03/1993
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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