3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D


Device Classification Name

system, x-ray, mobile

510(k) Number K022337
Device Name 3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
186 wood avenue south
iselin, 
NJ 
08830

Original Contact amy shaw hosler
Regulation Number 892.1720
Classification Product Code
IZL  
Date Received 07/18/2002
Decision Date 08/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No