TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915


Device Classification Name

system, x-ray, fluoroscopic, image-intensified

510(k) Number K022565
Device Name TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915
Original Applicant
STEREOTAXIS, INC.
4041 forest park ave.
st. louis, 
MO 
63108

Original Contact peter a takes
Regulation Number 892.1650
Classification Product Code
JAA  
Date Received 08/02/2002
Decision Date 10/08/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No