ARTISTE SOLUTION WITH SYS_VB50 UPDATE


Device Classification Name

accelerator, linear, medical

510(k) Number K103606
Device Name ARTISTE SOLUTION WITH SYS_VB50 UPDATE
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
4040 nelson ave.
concord, 
CA 
94520

Applicant Contact christine dunbar
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
4040 nelson ave.
concord, 
CA 
94520

Correspodent Contact christine dunbar
Regulation Number 892.5050
Classification Product Code
IYE  
Date Received 12/09/2010
Decision Date 04/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls