Shanghai United Imaging Healthcare Co., Ltd.
84 FDA 510(k) clearances · Manufacturer
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| Record | Firm | Date |
|---|---|---|
| uMI Panvivo (uMI Panvivo M) (K261427) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-07-28 |
| uMR Astra (K260113) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-05-22 |
| uOmnispace.MR (K253077) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-04-22 |
| uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) (K260524) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-04-03 |
| uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) (K253564) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-02-13 |
| uCT 780 with uWS-CT-Dual Energy Analysis (K253173) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-01-20 |
| uDR Arria & uDR Aris (K252000) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-11-26 |
| uMR 680 (K252371) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-25 |
| uWS-Angio Pro (K250045) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-24 |
| uDR Aurora CX (K251167) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-19 |
| uWS-Angio (K250040) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-12 |
| uMR Jupiter (K250246) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-08-05 |
| uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) (K251839) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-07-17 |
| uMR Ultra (K243547) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-07-17 |
| uMR 680 (K243397) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-07-16 |
| uOmniscan (K243666) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-06-17 |
| uMR Omega (K243122) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-21 |
| uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis (K243617) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-16 |
| Medical Image Post-processing Software (uOmnispace.CT) (K242624) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-14 |
| uWS-Angio Basic (K243632) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-12 |
| uAngio AVIVA CX (K243376) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-04-28 |
| uCT 550 (K241166) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-01-14 |
| uCT 780 (K241079) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-01-07 |
| uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) (K243538) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-12-12 |
| uDR 780i (K241068) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-11-01 |
| uDR 380i Pro (K242515) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-10-10 |
| uMI Panorama (K241585) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-08-30 |
| uMI Panvivo (K241596) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-08-15 |
| uPMR 790 (K234154) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-05-24 |
| uOmnispace.CT (K233209) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-05-17 |
| uMR Jupiter (K233673) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-04-26 |
| uOmnispace.MR (K233186) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-04-17 |
| uMR 680 (K240744) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-04-10 |
| uMR Omega (K240540) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-03-22 |
| uEXPLORER (K231762) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-01-18 |
| uOmnispace.MI (K233176) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-12-20 |
| uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis (K231482) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-11-29 |
| uMI Panorama (K232712) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-10-03 |
| uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis (K230162) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-08-01 |
| uMI Panorama (K231572) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-07-26 |
| uOmnispace (K230039) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-07-20 |
| uMR Omega (K230152) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-05-23 |
| uMR 570 (K230758) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-05-18 |
| uMI Panorama (K223325) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-03-10 |
| uCT ATLAS Astound with uWS-CT-Dual Energy Analysis (K223028) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-02-16 |
| uPMR 790 (K222540) | Shanghai United Imaging Healthcare Co., Ltd. | 2022-11-14 |
| uMR Omega with uWS-MR-MRS (K220332) | Shanghai United Imaging Healthcare Co., Ltd. | 2022-10-27 |
| uDR 380i Pro (K222339) | Shanghai United Imaging Healthcare Co., Ltd. | 2022-09-30 |
| uCT ATLAS with uWS-CT-Dual Energy Analysis (K203448) | Shanghai United Imaging Healthcare Co., Ltd. | 2021-08-11 |
| HYPER AiR (K210001) | Shanghai United Imaging Healthcare Co., Ltd. | 2021-04-30 |
| HYPER Focus (K210418) | Shanghai United Imaging Healthcare Co., Ltd. | 2021-04-09 |
| HYPER DLR (K193210) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-08-04 |
| uMR570 (K201540) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-07-06 |
| Deep Recon (K193073) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-07-06 |
| uWS-MI (K192630) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-06-11 |
| uWS-MR (K192601) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-06-01 |
| uMR 780 (K193176) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-05-05 |
| uMR 570 (K200024) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-04-20 |
| uMR Omega (K193200) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-03-27 |
| uCT 530, uCT 550 (K200016) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-02-25 |
| Emission Computed Tomography System (K193241) | Shanghai United Imaging Healthcare Co., Ltd. | 2020-01-26 |
| uMC 560i (K183144) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-12-19 |
| uPMR 790 (K192672) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-11-20 |
| uDR 592h, uDR 596i (K192293) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-09-12 |
| uWS-CT (K183170) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-06-24 |
| uMR 780, uMR 790 (K191157) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-05-29 |
| uWS-MR (K183164) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-03-22 |
| uPMR 790 (K183014) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-02-27 |
| Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24 (K183186) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-02-08 |
| uMR 580, uMR 588 (K183137) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-01-11 |
| Emission Computed Tomography System (K182938) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-12-18 |
| uWS-CT (K173001) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-11-07 |
| uWS-MR (K172999) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-11-07 |
| uMI 550 PET/CT System (K182237) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-10-12 |
| uMR 790 (K181371) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-10-03 |
| uMR 780 (K181370) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-10-03 |
| uCT 530, uCT 550 (K181414) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-08-14 |
| uDR 592h, uDR 596i (K181413) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-06-27 |
| uMR 560 (K180926) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-06-06 |
| uMR 570 (K180925) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-06-06 |
| uMI 780 PET/CT System (K172143) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-04-13 |
| uWS-MI (K172998) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-04-05 |
| uCT Computed Tomography X-ray System (K172135) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-03-02 |
| uDR 780i (K173953) | Shanghai United Imaging Healthcare Co., Ltd. | 2018-01-26 |
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