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
|
|
Correspondent Contact |
DAVID LEDWIG |
Regulation Number | 892.1680
|
Classification Product Code |
|
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
|
|
|