Device Classification Name |
system, x-ray, tomography, computed
|
510(k) Number |
K171201 |
Device Name |
NeuViz Prime Multi-slice CT Scanner System |
Applicant |
Neusoft Medical Systems Co., Ltd. |
No. 16, Shiji Road |
Hunnan Industrial Area |
Shenyang,
CN
110179
|
|
Applicant Contact |
Shao Xiancheng |
Correspondent |
Neusoft Medical Systems Co., Ltd. |
No. 16, Shiji Road |
Hunnan Industrial Area |
Shenyang,
CN
110179
|
|
Correspondent Contact |
Shao Xiancheng |
Regulation Number | 892.1750
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/24/2017 |
Decision Date | 09/13/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|