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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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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 (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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