Device Classification Name |
system, x-ray, stationary
|
510(k) Number |
K191699 |
Device Name |
Discovery XR656 HD with VolumeRad |
Applicant |
GE Hualun Medical Systems Co., Ltd |
No. 1 Yong Chang North Road, Economic Technological |
Development Zone |
Beijing,
CN
100176
|
|
Applicant Contact |
Chris Paulik |
Correspondent |
GE Hualun Medical Systems Co., Ltd |
No. 1 Yong Chang North Road, Economic Technological |
Development Zone |
Beijing,
CN
100176
|
|
Correspondent Contact |
Chris Paulik |
Regulation Number | 892.1680
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/25/2019 |
Decision Date | 07/24/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|