Device Classification Name |
solid state x-ray imager (flat panel/digital imager)
|
510(k) Number |
K111682 |
Device Name |
DIGITAL RADIOGRAPHY |
Applicant |
CANON, INC.-MEDICAL EQUIPMENT GROUP |
C/O COSMOS CORPORATION |
3F 2-17-6 AKEBONO-CHO |
TACHIKAWA-SHI, TOKYO,
JP
190-0012
|
|
Applicant Contact |
KOJI KUBO |
Correspondent |
CANON, INC.-MEDICAL EQUIPMENT GROUP |
C/O COSMOS CORPORATION |
3F 2-17-6 AKEBONO-CHO |
TACHIKAWA-SHI, TOKYO,
JP
190-0012
|
|
Correspondent Contact |
KOJI KUBO |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 06/15/2011 |
Decision Date | 09/02/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|