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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 K003510
Device Name INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500
Applicant
Visualization Technology, Inc.
200 Research Dr.
Wilmington,  MA  01887
Applicant Contact NORMA LEMAY
Correspondent
Visualization Technology, Inc.
200 Research Dr.
Wilmington,  MA  01887
Correspondent Contact NORMA LEMAY
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/14/2000
Decision Date 02/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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