4D LV-ANALYSIS 3.0


Device Classification Name

computer, diagnostic, programmable

510(k) Number K110746
Device Name 4D LV-ANALYSIS 3.0
Applicant
TOMTEC IMAGING SYSTEMS, GMBH
edisonstrasse 6
unterschleissheim, 

DE

d-85716

Applicant Contact inge scheidt
Correspondent
TOMTEC IMAGING SYSTEMS, GMBH
edisonstrasse 6
unterschleissheim, 

DE

d-85716

Correspodent Contact inge scheidt
Regulation Number 870.1425
Classification Product Code
DQK  
Subsequent Product Code
LLZ  
Date Received 03/17/2011
Decision Date 05/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No