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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 K983447
Device Name WISE (II) IMAGE MANAGEMENT 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 Received09/30/1998
Decision Date 10/29/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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