3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K030450
Device Name 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH
Applicant
J. MORITA USA, INC.
1425 k st. n.w.
suite 1100
washington, 
DC 
20005

Applicant Contact keith a barritt
Correspondent
J. MORITA USA, INC.
1425 k st. n.w.
suite 1100
washington, 
DC 
20005

Correspodent Contact keith a barritt
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 02/11/2003
Decision Date 05/06/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No