Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K040344 |
Device Name |
IMPAX OT3000 ORTHOPEDIC WORKSTATION |
Applicant |
AGFA CORP. |
455 PHILIP STREET |
WATERLOO, ONTARIO,
CA
N2L 3X2
|
|
Applicant Contact |
PHIL CUSCUNA |
Correspondent |
AGFA CORP. |
455 PHILIP STREET |
WATERLOO, ONTARIO,
CA
N2L 3X2
|
|
Correspondent Contact |
PHIL CUSCUNA |
Regulation Number | 892.2050
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/12/2004 |
Decision Date | 05/12/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|