Device Classification Name |
Automated Radiological Image Processing Software
|
510(k) Number |
K233209 |
Device Name |
uOmnispace.CT |
Applicant |
Shanghai United Imaging Healthcare Co., Ltd. |
No.2258 Chengbei Rd. |
Jiading District |
Shanghai,
CN
201807
|
|
Applicant Contact |
Gao Xin |
Correspondent |
Shanghai United Imaging Healthcare Co., Ltd. |
No.2258 Chengbei Rd. |
Jiading District |
Shanghai,
CN
201807
|
|
Correspondent Contact |
Xin Gao |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 09/28/2023 |
Decision Date | 05/17/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|