Device Classification Name |
solid state x-ray imager (flat panel/digital imager)
|
510(k) Number |
K122182 |
Device Name |
DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC |
Applicant |
RAYENCE CO., LTD |
12946 KIMBERLEY LN |
HOUSTON,
TX
77079
|
|
Applicant Contact |
DAVE KIM |
Correspondent |
RAYENCE CO., LTD |
12946 KIMBERLEY LN |
HOUSTON,
TX
77079
|
|
Correspondent Contact |
DAVE KIM |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 07/23/2012 |
Decision Date | 08/16/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|