AQUILION PRIME


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K110066
Device Name AQUILION PRIME
Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 michelle dr.
p.o. box 2068
tustin, 
CA 
92781 -2068

Applicant Contact paul biggins
Correspondent
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 michelle dr.
p.o. box 2068
tustin, 
CA 
92781 -2068

Correspodent Contact paul biggins
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 01/10/2011
Decision Date 01/26/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No