DX-D FULL LEG FULL SPINE


Device Classification Name

system, x-ray, stationary

510(k) Number K122119
Device Name DX-D FULL LEG FULL SPINE
Applicant
AFGA HEALTHCARE N.V.
po box 1927
brevard, 
NC 
28712

Applicant Contact david ledwig
Correspondent
AFGA HEALTHCARE N.V.
po box 1927
brevard, 
NC 
28712

Correspodent Contact david ledwig
Regulation Number 892.1680
Classification Product Code
KPR  
Date Received 07/17/2012
Decision Date 09/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No