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Shanghai United Imaging Healthcare Co., Ltd.

FDA 510(k) & PMA Approved Devices — 82 products

Total Devices82
Categories10
Latest Approval2026-04-22
TypeNumberDevice NameCodeDate
510(k) K253077 uOmnispace.MR QIH 2026-04-22 View
510(k) K260524 uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) KPS 2026-04-03 View
510(k) K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) KPS 2026-02-13 View
510(k) K253173 uCT 780 with uWS-CT-Dual Energy Analysis JAK 2026-01-20 View
510(k) K252000 uDR Arria & uDR Aris KPR 2025-11-26 View
510(k) K252371 uMR 680 LNH 2025-09-25 View
510(k) K250045 uWS-Angio Pro LLZ 2025-09-24 View
510(k) K251167 uDR Aurora CX KPR 2025-09-19 View
510(k) K250040 uWS-Angio LLZ 2025-09-12 View
510(k) K250246 uMR Jupiter LNH 2025-08-05 View
510(k) K251839 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) KPS 2025-07-17 View
510(k) K243547 uMR Ultra LNH 2025-07-17 View
510(k) K243397 uMR 680 LNH 2025-07-16 View
510(k) K243666 uOmniscan LLZ 2025-06-17 View
510(k) K243122 uMR Omega LNH 2025-05-21 View
510(k) K243617 uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis JAK 2025-05-16 View
510(k) K242624 Medical Image Post-processing Software (uOmnispace.CT) QIH 2025-05-14 View
510(k) K243632 uWS-Angio Basic LLZ 2025-05-12 View
510(k) K243376 uAngio AVIVA CX OWB 2025-04-28 View
510(k) K241166 uCT 550 JAK 2025-01-14 View
510(k) K241079 uCT 780 JAK 2025-01-07 View
510(k) K243538 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) KPS 2024-12-12 View
510(k) K241068 uDR 780i KPR 2024-11-01 View
510(k) K242515 uDR 380i Pro IZL 2024-10-10 View
510(k) K241585 uMI Panorama KPS 2024-08-30 View
510(k) K241596 uMI Panvivo KPS 2024-08-15 View
510(k) K234154 uPMR 790 OUO 2024-05-24 View
510(k) K233209 uOmnispace.CT QIH 2024-05-17 View
510(k) K233673 uMR Jupiter LNH 2024-04-26 View
510(k) K233186 uOmnispace.MR QIH 2024-04-17 View
510(k) K240744 uMR 680 LNH 2024-04-10 View
510(k) K240540 uMR Omega LNH 2024-03-22 View
510(k) K231762 uEXPLORER KPS 2024-01-18 View
510(k) K233176 uOmnispace.MI LLZ 2023-12-20 View
510(k) K231482 uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis JAK 2023-11-29 View
510(k) K232712 uMI Panorama KPS 2023-10-03 View
510(k) K230162 uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis JAK 2023-08-01 View
510(k) K231572 uMI Panorama KPS 2023-07-26 View
510(k) K230039 uOmnispace QIH 2023-07-20 View
510(k) K230152 uMR Omega LNH 2023-05-23 View
510(k) K230758 uMR 570 LNH 2023-05-18 View
510(k) K223325 uMI Panorama KPS 2023-03-10 View
510(k) K223028 uCT ATLAS Astound with uWS-CT-Dual Energy Analysis JAK 2023-02-16 View
510(k) K222540 uPMR 790 OUO 2022-11-14 View
510(k) K220332 uMR Omega with uWS-MR-MRS LNH 2022-10-27 View
510(k) K222339 uDR 380i Pro IZL 2022-09-30 View
510(k) K203448 uCT ATLAS with uWS-CT-Dual Energy Analysis JAK 2021-08-11 View
510(k) K210001 HYPER AiR KPS 2021-04-30 View
510(k) K210418 HYPER Focus KPS 2021-04-09 View
510(k) K193210 HYPER DLR KPS 2020-08-04 View
510(k) K201540 uMR570 LNH 2020-07-06 View
510(k) K193073 Deep Recon JAK 2020-07-06 View
510(k) K192630 uWS-MI LLZ 2020-06-11 View
510(k) K192601 uWS-MR QIH 2020-06-01 View
510(k) K193176 uMR 780 LNH 2020-05-05 View
510(k) K200024 uMR 570 LNH 2020-04-20 View
510(k) K193200 uMR Omega LNH 2020-03-27 View
510(k) K200016 uCT 530, uCT 550 JAK 2020-02-25 View
510(k) K193241 Emission Computed Tomography System KPS 2020-01-26 View
510(k) K183144 uMC 560i OWB 2019-12-19 View
510(k) K192672 uPMR 790 OUO 2019-11-20 View
510(k) K192293 uDR 592h, uDR 596i KPR 2019-09-12 View
510(k) K183170 uWS-CT LLZ 2019-06-24 View
510(k) K191157 uMR 780, uMR 790 LNH 2019-05-29 View
510(k) K183164 uWS-MR LLZ 2019-03-22 View
510(k) K183014 uPMR 790 OUO 2019-02-27 View
510(k) K183186 Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24 MOS 2019-02-08 View
510(k) K183137 uMR 580, uMR 588 LNH 2019-01-11 View
510(k) K182938 Emission Computed Tomography System KPS 2018-12-18 View
510(k) K173001 uWS-CT LLZ 2018-11-07 View
510(k) K172999 uWS-MR LLZ 2018-11-07 View
510(k) K182237 uMI 550 PET/CT System KPS 2018-10-12 View
510(k) K181371 uMR 790 LNH 2018-10-03 View
510(k) K181370 uMR 780 LNH 2018-10-03 View
510(k) K181414 uCT 530, uCT 550 JAK 2018-08-14 View
510(k) K181413 uDR 592h, uDR 596i KPR 2018-06-27 View
510(k) K180926 uMR 560 LNH 2018-06-06 View
510(k) K180925 uMR 570 LNH 2018-06-06 View
510(k) K172143 uMI 780 PET/CT System KPS 2018-04-13 View
510(k) K172998 uWS-MI LLZ 2018-04-05 View
510(k) K172135 uCT Computed Tomography X-ray System JAK 2018-03-02 View
510(k) K173953 uDR 780i KPR 2018-01-26 View
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