CEDARA I-SOFTVIEW


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 Number 892.2050
Classification Product Code
LLZ  
Date Received 08/30/2002
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