MODIFICATION TO INREACH SYSTEM


Device Classification Name

system, x-ray, tomography, computed

510(k) Number K081379
Device Name MODIFICATION TO INREACH SYSTEM
Applicant
SUPERDIMENSION, LTD.
161 cheshire lane north,
suite 100
minneapolis, 
MN 
55441 -5433

Applicant Contact jonathan kovach
Correspondent
SUPERDIMENSION, LTD.
161 cheshire lane north,
suite 100
minneapolis, 
MN 
55441 -5433

Correspodent Contact jonathan kovach
Regulation Number 892.1750
Classification Product Code
JAK  
Date Received 05/16/2008
Decision Date 06/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No