Device Classification Name |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
|
510(k) Number |
K041701 |
Device Name |
AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM |
Applicant |
AGFA CORP. |
10 SOUTH ACADEMY ST. |
GREENVILLE,
SC
29601
|
|
Applicant Contact |
JEFFERY A JEDLICKA |
Correspondent |
AGFA CORP. |
10 SOUTH ACADEMY ST. |
GREENVILLE,
SC
29601
|
|
Correspondent Contact |
JEFFERY A JEDLICKA |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 06/22/2004 |
Decision Date | 07/22/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|