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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K943994
Device Name PACS EQUIPMENT
Applicant
Rstar Image Management System
One Cambridge Center
Cambridge,  MA  02142
Applicant Contact MORTEZA MINAEE
Correspondent
Rstar Image Management System
One Cambridge Center
Cambridge,  MA  02142
Correspondent Contact MORTEZA MINAEE
Regulation Number892.2020
Classification Product Code
LMD  
Date Received08/16/1994
Decision Date 05/12/1995
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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