SYNGO.CT VASCULAR ANALYSIS


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K112020
Device Name SYNGO.CT VASCULAR ANALYSIS
Applicant
SIEMENS MEDICAL SOLUTIONS, INC.
51 valley stream parkway
malvern, 
PA 
19355

Applicant Contact ralf hofmann
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 07/14/2011
Decision Date 08/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No