AQUILION LB MOVEMENT BASE KIT


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K111633
Device Name AQUILION LB MOVEMENT BASE KIT
Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 michelle dr
tustin, 
CA 
92780

Applicant Contact paul biggins
Correspondent
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 michelle dr
tustin, 
CA 
92780

Correspodent Contact paul biggins
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 06/13/2011
Decision Date 08/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No