Device Classification Name |
Camera, Multi Format, Radiological
|
510(k) Number |
K022658 |
Device Name |
LR DICOM CONTROLLER |
Applicant |
AGFA CORP. |
10 SOUTH ACADEMY ST. |
GREENVILLE,
SC
29601
|
|
Applicant Contact |
JEFF JEDLICKA |
Correspondent |
AGFA CORP. |
10 SOUTH ACADEMY ST. |
GREENVILLE,
SC
29601
|
|
Correspondent Contact |
JEFF JEDLICKA |
Regulation Number | 892.2040
|
Classification Product Code |
|
Date Received | 08/09/2002 |
Decision Date | 09/06/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|