AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K072606
Device Name AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM
Applicant
TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
2441 michelle dr.
tustin, 
CA 
92780

Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 09/17/2007
Decision Date 10/02/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls