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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 K936179
Device Name WINRAD TELERADIOLOGY SYSTEM
Applicant
Line Imaging Systems
1250 Mclynn Ave.
Atlanta,  GA  30306
Applicant Contact JOHN E SCHWARTZBERG
Correspondent
Line Imaging Systems
1250 Mclynn Ave.
Atlanta,  GA  30306
Correspondent Contact JOHN E SCHWARTZBERG
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/27/1993
Decision Date 08/25/1994
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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