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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K980970
Device Name IIRAD DIRECTRAY OPERATOR CONSOLE
Applicant
Sterling Diagnostic Imaging, Inc.
10 S. Academy St.
Mail Drop 120
Greenville,  SC  29601
Applicant Contact JEAN E BARTLETT
Correspondent
Sterling Diagnostic Imaging, Inc.
10 S. Academy St.
Mail Drop 120
Greenville,  SC  29601
Correspondent Contact JEAN E BARTLETT
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/16/1998
Decision Date 06/08/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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