CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER


codes

Device Classification Name

system, image processing, radiological

510(k) Number K002590
Device Name CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER
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 08/21/2000
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