4D SONO-SCAN 1.0


Device Classification Name

system, image processing, radiological

510(k) Number K110595
Device Name 4D SONO-SCAN 1.0
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 892.2050
Classification Product Code
LLZ  
Date Received 03/02/2011
Decision Date 04/07/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No