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Shanghai United Imaging Healthcare Co., Ltd.

FDA 510(k) & PMA Approved Devices — 84 products

Total Devices84
Categories10
Latest FDA decision2026-07-28
TypeNumberDevice NameCodeDateActions
510(k) K230039 uOmnispaceQIH2023-07-20 View
510(k) K230152 uMR OmegaLNH2023-05-23 View
510(k) K230758 uMR 570LNH2023-05-18 View
510(k) K223325 uMI PanoramaKPS2023-03-10 View
510(k) K223028 uCT ATLAS Astound with uWS-CT-Dual Energy AnalysisJAK2023-02-16 View
510(k) K222540 uPMR 790OUO2022-11-14 View
510(k) K220332 uMR Omega with uWS-MR-MRSLNH2022-10-27 View
510(k) K222339 uDR 380i ProIZL2022-09-30 View
510(k) K203448 uCT ATLAS with uWS-CT-Dual Energy AnalysisJAK2021-08-11 View
510(k) K210001 HYPER AiRKPS2021-04-30 View
510(k) K210418 HYPER FocusKPS2021-04-09 View
510(k) K193210 HYPER DLRKPS2020-08-04 View
510(k) K201540 uMR570LNH2020-07-06 View
510(k) K193073 Deep ReconJAK2020-07-06 View
510(k) K192630 uWS-MILLZ2020-06-11 View
510(k) K192601 uWS-MRQIH2020-06-01 View
510(k) K193176 uMR 780LNH2020-05-05 View
510(k) K200024 uMR 570LNH2020-04-20 View
510(k) K193200 uMR OmegaLNH2020-03-27 View
510(k) K200016 uCT 530, uCT 550JAK2020-02-25 View

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