Device Classification Name |
System, X-Ray, Tomography, Computed
|
510(k) Number |
K172135 |
Device Name |
uCT Computed Tomography X-ray System |
Applicant |
Shanghai United Imaging Healthcare Co., Ltd. |
No. 2258 Chengbei Rd., Jiading Industrial District |
Shanghai,
CN
201807
|
|
Applicant Contact |
Shumei Wang |
Correspondent |
Shanghai United Imaging Healthcare Co., Ltd. |
No. 2258 Chengbei Rd., Jiading Industrial District |
Shanghai,
CN
201807
|
|
Correspondent Contact |
Shumei Wang |
Regulation Number | 892.1750
|
Classification Product Code |
|
Date Received | 07/14/2017 |
Decision Date | 03/02/2018 |
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
|
|
|