3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A


the company

Device Classification Name

system, image processing, radiological

510(k) Number K002424
Device Name 3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A
Original Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 michelle dr.
p.o. box 2068
tustin, 
CA 
92781 -2068

Original Contact diana thorson
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 08/08/2000
Decision Date 10/27/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No