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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 K896095
Device Name IMAGES-ON-CALL TELERADIOLOGY SYSTEM
Applicant
Devices & Services Co.
10024 Monroe Dr.
Dallas,  TX  75229
Applicant Contact TOM S ASHLEY
Correspondent
Devices & Services Co.
10024 Monroe Dr.
Dallas,  TX  75229
Correspondent Contact TOM S ASHLEY
Regulation Number892.2020
Classification Product Code
LMD  
Date Received10/20/1989
Decision Date 02/16/1990
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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