Device Classification Name |
solid state x-ray imager (flat panel/digital imager)
|
510(k) Number |
K232058 |
Device Name |
YosemiteView 4343W/YosemiteView 3643W |
Applicant |
CareRay Digital Medical Technology Co., Ltd. |
A2-201/B3-501, Biobay,218 Xinghu Street, |
SuZhou Industrial Park, |
Suzhou,
CN
215123
|
|
Applicant Contact |
Xu Wei |
Correspondent |
CareRay Digital Medical Technology Co., Ltd. |
A2-201/B3-501, Biobay,218 Xinghu Street, |
SuZhou Industrial Park, |
Suzhou,
CN
215123
|
|
Correspondent Contact |
Xu Wei |
Regulation Number | 892.1680
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/11/2023 |
Decision Date | 08/03/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|