ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21


Device Classification Name

interventional fluoroscopic x-ray system

510(k) Number K122644
Device Name ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 valley stream pkwy.
malvern, 
PA 
19355 -1406

Applicant Contact patricia d jones
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 valley stream pkwy.
malvern, 
PA 
19355 -1406

Correspodent Contact patricia d jones
Regulation Number 892.1650
Classification Product Code
OWB  
Date Received 08/29/2012
Decision Date 05/16/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No