SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLY


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K073003
Device Name SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLY
Applicant
SIEMENS MEDICAL SOLUTIONS, INC.
51 valley stream parkway
malvern, 
PA 
19355

Applicant Contact corrine mcleod
Correspondent
SIEMENS MEDICAL SOLUTIONS, INC.
51 valley stream parkway
malvern, 
PA 
19355

Correspodent Contact corrine mcleod
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 10/24/2007
Decision Date 02/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No