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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
Applicant
CEDARA SOFTWARE CORP.
6509 AIRPORT RD.
MISSISSAUGA, ONTARIO,  CA L4V 1S7
Applicant Contact CAROL NAKAGAWA
Correspondent
CEDARA SOFTWARE CORP.
6509 AIRPORT RD.
MISSISSAUGA, ONTARIO,  CA L4V 1S7
Correspondent 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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