FDA 510(k) Applications Submitted by Xin Gao
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K200016 |
01/03/2020 |
uCT 530, uCT 550 |
Shanghai United Imaging Healthcare Co., Ltd. |
K210001 |
01/04/2021 |
HYPER AiR |
Shanghai United Imaging Healthcare Co.,Ltd. |
K200024 |
01/06/2020 |
uMR 570 |
Shanghai United Imaging Healthcare Co., Ltd. |
K230152 |
01/19/2023 |
uMR Omega |
Shanghai United Imaging Healthcare Co., Ltd. |
K230162 |
01/20/2023 |
uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis |
Shanghai United Imaging Healthcare Co., Ltd. |
K220332 |
02/04/2022 |
uMR Omega with uWS-MR-MRS |
Shanghai United Imaging Healthcare Co.,Ltd. |
K210418 |
02/11/2021 |
HYPER Focus |
Shanghai United Imaging Healthcare Co.,Ltd. |
K230758 |
03/20/2023 |
uMR 570 |
Shanghai United Imaging Healthcare Co.,Ltd. |
K191157 |
05/01/2019 |
uMR 780, uMR 790 |
Shanghai United Imaging Healthcare Co., Ltd. |
K181370 |
05/23/2018 |
uMR 780 |
Shanghai United Imaging Healthcare Co., Ltd. |
K181371 |
05/23/2018 |
uMR 790 |
Shanghai United Imaging Healthcare Co.,Ltd. |
K231572 |
05/31/2023 |
uMI Panorama |
Shanghai United Imaging Healthcare Co., Ltd. |
K201540 |
06/09/2020 |
uMR570 |
Shanghai United Imaging Healthcare Co.,Ltd. |
K222339 |
08/03/2022 |
uDR 380i Pro |
Shanghai United Imaging Healthcare Co., Ltd. |
K222540 |
08/22/2022 |
uPMR 790 |
Shanghai United Imaging Healthcare Co., Ltd. |
K192293 |
08/23/2019 |
uDR 592h, uDR 596i |
Shanghai United Imaging Healthcare Co., Ltd. |
K232712 |
09/05/2023 |
uMI Panorama |
Shanghai United Imaging Healthcare Co., Ltd. |
K222755 |
09/12/2022 |
uMR 680 |
Shanghai United Imaging Intelligence Co., Ltd. |
K192601 |
09/20/2019 |
uWS-MR |
Shanghai United Imaging Healthcare Co., Ltd |
K192630 |
09/23/2019 |
uWS-MI |
Shanghai United Imaging Healthcare Co., Ltd. |
K192672 |
09/26/2019 |
uPMR 790 |
Shanghai United Imaging Healthcare Co., Ltd |
K223028 |
09/29/2022 |
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis |
Shanghai United Imaging Healthcare Co., Ltd. |
K223325 |
10/31/2022 |
uMI Panorama |
Shanghai United Imaging Healthcare Co., Ltd. |
K183137 |
11/13/2018 |
uMR 580, uMR 588 |
Shanghai United Imaging Healthcare Co., Ltd. |
K183164 |
11/15/2018 |
uWS-MR |
Shanghai United Imaging Healthcare Co., Ltd. |
K183170 |
11/16/2018 |
uWS-CT |
Shanghai United Imaging Healthcare Co., Ltd. |
K193176 |
11/18/2019 |
uMR 780 |
Shanghai United Imaging Healthcare Co., Ltd |
K183186 |
11/19/2018 |
Head Coil û 12, Head Coil û 32, Carotid Coil û 8, Temporomandibular Joint Coil û 4, Infant Coil û 24, Cardiac Coil û 24, Foot & Ankle Coil - 24 |
Shanghai United Imaging Healthcare Co., Ltd. |
K193200 |
11/20/2019 |
uMR Omega |
Shanghai United Imaging Healthcare Co., Ltd. |
K203448 |
11/23/2020 |
uCT ATLAS with uWS-CT-Dual Energy Analysis |
Shanghai United Imaging Healthcare Co., Ltd. |
K173953 |
12/27/2017 |
uDR 780i |
Shanghai United Imaging Healthcare Co., Ltd. |
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