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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 K925994
Device Name RSTAR IMAGE MANAGMENT SYTEM (RSTAR-IMS)
Applicant
Rstar, Inc.
One Cambridge Center
Cambridge,  MA  02142
Applicant Contact MARIA KALDIS
Correspondent
Rstar, Inc.
One Cambridge Center
Cambridge,  MA  02142
Correspondent Contact MARIA KALDIS
Regulation Number892.2020
Classification Product Code
LMD  
Date Received11/27/1992
Decision Date 03/18/1993
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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