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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 K980220
Device Name IISYS PACS SYSTEM
Applicant
Sterling Diagnostic Imaging, Inc.
10 S. Academy St.
Mail Drop 120
Greenville,  SC  29601
Applicant Contact TIMOTHY W CAPEHART
Correspondent
Sterling Diagnostic Imaging, Inc.
10 S. Academy St.
Mail Drop 120
Greenville,  SC  29601
Correspondent Contact TIMOTHY W CAPEHART
Regulation Number892.2020
Classification Product Code
LMD  
Date Received01/22/1998
Decision Date 02/13/1998
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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