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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 K002590
Device Name CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER
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 Received08/21/2000
Decision Date 10/31/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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