Device Classification Name |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
|
510(k) Number |
K122736 |
Device Name |
DX-D IMAGING PACKAGE |
Applicant |
AGFA HEALTHCARE N.V. |
PO BOX 1927 |
BREVARD,
NC
28712
|
|
Applicant Contact |
DAVID LEDWIG |
Correspondent |
AGFA HEALTHCARE N.V. |
PO BOX 1927 |
BREVARD,
NC
28712
|
|
Correspondent Contact |
DAVID LEDWIG |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 09/19/2012 |
Decision Date | 03/11/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|