Device Classification Name |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
|
510(k) Number |
K122928 |
Device Name |
DIGITAL FLAT PANEL X-RAY DETECTOR/1417PGA |
Applicant |
RAYENCE CO., LTD |
8310 BUFFALO SPEEDWAY |
HOUSTON,
TX
77025
|
|
Applicant Contact |
DAVE KIM |
Correspondent |
RAYENCE CO., LTD |
8310 BUFFALO SPEEDWAY |
HOUSTON,
TX
77025
|
|
Correspondent Contact |
DAVE KIM |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 09/24/2012 |
Decision Date | 01/30/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|