CSBP-001A BODY ORGAN PERFUSION SYSTEM


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K081482
Device Name CSBP-001A BODY ORGAN PERFUSION SYSTEM
Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 michelle dr.
p.o. box 2068
tustin, 
CA 
92781 -2068

Applicant Contact paul biggins
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 05/28/2008
Decision Date 06/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No