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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Digital Image Storage, Radiological
510(k) Number K963395
Device Name IMAGESERVER 2000 PICTURE ARCHIVING 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 Number892.2010
Classification Product Code
LMB  
Date Received08/28/1996
Decision Date 10/25/1996
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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