Device Classification Name |
system, image processing, radiological
|
510(k) Number |
K053458 |
Device Name |
WEB1000 |
Applicant |
AGFA CORP. |
455 PHILIP STREET |
WATERLOO, ONTARIO,
CA
N2L 3X2
|
|
Applicant Contact |
PHIL CUSCUNA |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
12 LABORATORY DR. |
RESEARCH TRIANGLE,
NC
27709
|
|
Correspondent Contact |
JEFFREY D RONGERO |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 12/13/2005 |
Decision Date | 12/22/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|