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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 K954691
Device Name ACCESS RADIOLOGY TELERADIOLOGY IMAGE ACQUISITION & DISTRIBUTION SYSTEM
Applicant
Access Radiology Corp.
One Financial Center
Boston,  MA  02111
Applicant Contact CAROLYN S LANGER
Correspondent
Access Radiology Corp.
One Financial Center
Boston,  MA  02111
Correspondent Contact CAROLYN S LANGER
Regulation Number892.2020
Classification Product Code
LMD  
Date Received10/11/1995
Decision Date 03/29/1996
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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