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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 K022881
Device Name CEDARA I-SOFTVIEW
Original Applicant
CEDARA SOFTWARE CORP.
6509 airport rd.
mississauga, ontario,  CA l4v 1s7
Original Contact carol nakagawa
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/30/2002
Decision Date 10/22/2002
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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