I-DIXEL


Device Classification Name

system, image processing, radiological

510(k) Number K073704
Device Name I-DIXEL
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 892.2050
Classification Product Code
LLZ  
Date Received 12/31/2007
Decision Date 02/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No