SYNGO.CT CARDIAC FUNCTION


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K110366
Device Name SYNGO.CT CARDIAC FUNCTION
Applicant
SIEMENS AG
51 valley stream pkwy
malvern, 
PA 
19355

Applicant Contact ralf hoffmann
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 02/07/2011
Decision Date 04/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No