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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 K960330
Device Name INSTATRAK
Applicant
VISUALIZATION TECHNOLOGY, INC.
30G SIXTH RD.
WOBURN,  MA  01801
Applicant Contact ROBERT R MURFITT
Correspondent
VISUALIZATION TECHNOLOGY, INC.
30G SIXTH RD.
WOBURN,  MA  01801
Correspondent Contact ROBERT R MURFITT
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/24/1996
Decision Date 04/08/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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