ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.X, LV ANALYSIS 1.X & SURGICAL VIEW 1.X


Device Classification Name

system, image processing, radiological

510(k) Number K022824
Device Name ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.X, LV ANALYSIS 1.X & SURGICAL VIEW 1.X
Original Applicant
TOMTEC IMAGING SYSTEMS, GMBH
edisonstrasse 6
unterschleissheim, 

DE

d-85716

Original Contact florian eisenberger
Regulation Number 892.2050
Classification Product Code
LLZ  
Subsequent Product Code
IYO  
Date Received 08/26/2002
Decision Date 10/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No