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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 K961983
Device Name TRS 2000 TELERADIOLOGY SYSTEM
Applicant
Sectra-Imtec AB
6741 Grant Ln.
Plano,  TX  75024
Applicant Contact HERMAN OOSTERWIJK
Correspondent
Sectra-Imtec AB
6741 Grant Ln.
Plano,  TX  75024
Correspondent Contact HERMAN OOSTERWIJK
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/20/1996
Decision Date 08/13/1996
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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