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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 K983529
Device Name INSTATRAK 3000
Applicant
VISUALIZATION TECHNOLOGY, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760 -4153
Applicant Contact MARY MCNAMARA-CULLINANE
Correspondent
VISUALIZATION TECHNOLOGY, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760 -4153
Correspondent Contact MARY MCNAMARA-CULLINANE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/08/1998
Decision Date 12/31/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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