Device Classification Name |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
|
510(k) Number |
K091435 |
Device Name |
DIGITAL RADIOGRAPHY MODEL CXDI-55G |
Applicant |
CANON INC. |
ONE CANON PLAZA |
LAKE SUCCESS,
NY
11042
|
|
Applicant Contact |
SHEILA DRISCOLL |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
12 LABORATORY DR. |
RESEARCH TRIANGLE,
NC
27709
|
|
Correspondent Contact |
JEFF D RONGERO |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 05/14/2009 |
Decision Date | 05/29/2009 |
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
|
|
|