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39 devices · 3 companies · 2020 to 2026

Shanghai United Imaging Healthcare Co., Ltd.: AI-enabled devices on FDA's list

39 devices from Shanghai United Imaging Healthcare Co., Ltd., 2020 to 2026, from 3 companies across 8 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (39 of 39 here), the regulation, and MAUDE report counts by product code.

Retrieved from FDA public records.

Product codes from Shanghai United Imaging Healthcare Co., Ltd.

Every device, newest decision first

Shanghai United Imaging Healthcare Co., Ltd. · 39 devices
DecisionDevicePanelProduct codeFDA
uMR AstraK260113 · 510(k)RadiologyLNHdatabase entry
uOmnispace.MRK253077 · 510(k)RadiologyQIHdatabase entry
uMI PanvivoK260524 · 510(k)RadiologyKPSdatabase entry
uMI PanvivoK253564 · 510(k)RadiologyKPSdatabase entry
uCT 780 with uWS-CT-Dual Energy AnalysisK253173 · 510(k)RadiologyJAKdatabase entry
uMR 680K252371 · 510(k)RadiologyLNHdatabase entry
uDR Aurora CXK251167 · 510(k)RadiologyKPRdatabase entry
uMR JupiterK250246 · 510(k)RadiologyLNHdatabase entry
uMR UltraK243547 · 510(k)RadiologyLNHdatabase entry
uMI PanvivoK251839 · 510(k)RadiologyKPSdatabase entry
uMR 680K243397 · 510(k)RadiologyLNHdatabase entry
uMR OmegaK243122 · 510(k)RadiologyLNHdatabase entry
uCT ATLAS Astound with uWS-CT-Dual Energy AnalysK243617 · 510(k)RadiologyJAKdatabase entry
Medical Image Post-processing SoftwareK242624 · 510(k)RadiologyQIHdatabase entry
uAngio AVIVA CXK243376 · 510(k)RadiologyOWBdatabase entry
uCT 550K241166 · 510(k)RadiologyJAKdatabase entry
uCT 780K241079 · 510(k)RadiologyJAKdatabase entry
uMI PanvivoK243538 · 510(k)RadiologyKPSdatabase entry
uMI PanoramaK241585 · 510(k)RadiologyKPSdatabase entry
uMI PanvivoK241596 · 510(k)RadiologyKPSdatabase entry
uPMR 790K234154 · 510(k)RadiologyOUOdatabase entry
uOmnispace.CTK233209 · 510(k)RadiologyQIHdatabase entry
uMR JupiterK233673 · 510(k)RadiologyLNHdatabase entry
uOmnispace.MRK233186 · 510(k)RadiologyQIHdatabase entry
uMR 680K240744 · 510(k)RadiologyLNHdatabase entry
uMR OmegaK240540 · 510(k)RadiologyLNHdatabase entry
uOmnispace.MIK233176 · 510(k)RadiologyLLZdatabase entry
uMI PanoramaK232712 · 510(k)RadiologyKPSdatabase entry
uMI PanoramaK231572 · 510(k)RadiologyKPSdatabase entry
uOmnispaceK230039 · 510(k)RadiologyQIHdatabase entry
uMI PanoramaK223325 · 510(k)RadiologyKPSdatabase entry
uCT ATLAS Astound with uWS-CT-Dual Energy AnalysK223028 · 510(k)RadiologyJAKdatabase entry
uMR Omega with uWS-MR-MRSK220332 · 510(k)RadiologyLNHdatabase entry
uCT ATLAS with uWS-CT-Dual Energy AnalysisK203448 · 510(k)RadiologyJAKdatabase entry
HYPER AiRK210001 · 510(k)RadiologyKPSdatabase entry
HYPER DLRK193210 · 510(k)RadiologyKPSdatabase entry
Deep ReconK193073 · 510(k)RadiologyJAKdatabase entry
uWS-MRK192601 · 510(k)RadiologyQIHdatabase entry
uMR 780K193176 · 510(k)RadiologyLNHdatabase entry

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