Device Classification Name |
solid state x-ray imager (flat panel/digital imager)
|
510(k) Number |
K201796 |
Device Name |
1717SCV, 1717SGV |
Applicant |
Rayence Co., Ltd. |
14, Samsung 1-ro 1-gil |
Hwaseong-si,
KR
|
|
Applicant Contact |
Kee Dock Kim |
Correspondent |
Mtech Group |
7707 Fannin St. Ste 200, V111 |
Houston,
TX
77054
|
|
Correspondent Contact |
Dave Kim |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 06/30/2020 |
Decision Date | 07/23/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|