Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K050751 |
Device Name |
IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X |
Applicant |
AGFA CORP. |
10 SOUTH ACADEMY ST. |
GREENVILLE,
SC
29601
|
|
Applicant Contact |
PHIL CUSCUNA |
Correspondent |
AGFA CORP. |
10 SOUTH ACADEMY ST. |
GREENVILLE,
SC
29601
|
|
Correspondent Contact |
PHIL CUSCUNA |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 03/23/2005 |
Decision Date | 04/21/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|