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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
Recalls CDRH Recalls
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