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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 K062237
Device Name CADI, VERSION 4
Applicant
SYNCA MARKETING, INC.
337 MARION STREET
LE GARDEUR, QUEBEC,  CA J5Z 4W8
Applicant Contact STEPHANE ARSENAULT
Correspondent
SYNCA MARKETING, INC.
337 MARION STREET
LE GARDEUR, QUEBEC,  CA J5Z 4W8
Correspondent Contact STEPHANE ARSENAULT
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/02/2006
Decision Date 11/20/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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