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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) K261427 uMI Panvivo (uMI Panvivo M)KPS2026-07-28 View
510(k) K260113 uMR AstraLNH2026-05-22 View
510(k) K253077 uOmnispace.MRQIH2026-04-22 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)KPS2026-04-03 View
510(k) K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)KPS2026-02-13 View
510(k) K253173 uCT 780 with uWS-CT-Dual Energy AnalysisJAK2026-01-20 View
510(k) K252000 uDR Arria & uDR ArisKPR2025-11-26 View
510(k) K252371 uMR 680LNH2025-09-25 View
510(k) K250045 uWS-Angio ProLLZ2025-09-24 View
510(k) K251167 uDR Aurora CXKPR2025-09-19 View
510(k) K250040 uWS-AngioLLZ2025-09-12 View
510(k) K250246 uMR JupiterLNH2025-08-05 View
510(k) K251839 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)KPS2025-07-17 View
510(k) K243547 uMR UltraLNH2025-07-17 View
510(k) K243397 uMR 680LNH2025-07-16 View
510(k) K243666 uOmniscanLLZ2025-06-17 View
510(k) K243122 uMR OmegaLNH2025-05-21 View
510(k) K243617 uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy AnalysisJAK2025-05-16 View
510(k) K242624 Medical Image Post-processing Software (uOmnispace.CT)QIH2025-05-14 View
510(k) K243632 uWS-Angio BasicLLZ2025-05-12 View

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