IMAGE-COM 5.0


Device Classification Name

system, image processing, radiological

510(k) Number K122289
Device Name IMAGE-COM 5.0
Applicant
TOM TEC IMAGING SYSTEMS GMBH
edisonstr. 6
unterschleissheim, 

DE

85716

Applicant Contact bernhard mumm
Correspondent
TOM TEC IMAGING SYSTEMS GMBH
edisonstr. 6
unterschleissheim, 

DE

85716

Correspodent Contact bernhard mumm
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 07/30/2012
Decision Date 10/24/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No