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Shanghai United Imaging Healthcare Co., Ltd. FDA Approvals
0 new drug approvals and 52 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| uAngio AVIVA CX510(k)Aug 21, 2026Radiology |
| uMI Panvivo (uMI Panvivo M)510(k)Jul 28, 2026Radiology |
| uMR Astra510(k)May 22, 2026Radiology |
| uOmnispace.MR510(k)Apr 22, 2026Radiology |
| uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)510(k)Apr 3, 2026Radiology |
| uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)510(k)Feb 13, 2026Radiology |
| uCT 780 with uWS-CT-Dual Energy Analysis510(k)Jan 20, 2026Radiology |
| uDR Arria & uDR Aris510(k)Nov 26, 2025Radiology |
| uMR 680510(k)Sep 25, 2025Radiology |
| uWS-Angio Pro510(k)Sep 24, 2025Radiology |
| uDR Aurora CX510(k)Sep 19, 2025Radiology |
| uWS-Angio510(k)Sep 12, 2025Radiology |
| uMR Jupiter510(k)Aug 5, 2025Radiology |
| uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)510(k)Jul 17, 2025Radiology |
| uMR Ultra510(k)Jul 17, 2025Radiology |
| uMR 680510(k)Jul 16, 2025Radiology |
| uOmniscan510(k)Jun 17, 2025Radiology |
| uMR Omega510(k)May 21, 2025Radiology |
| uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis510(k)May 16, 2025Radiology |
| Medical Image Post-processing Software (uOmnispace.CT)510(k)May 14, 2025Radiology |
| uWS-Angio Basic510(k)May 12, 2025Radiology |
| uAngio AVIVA CX510(k)Apr 28, 2025Radiology |
| uCT 550510(k)Jan 14, 2025Radiology |
| uCT 780510(k)Jan 7, 2025Radiology |
| uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)510(k)Dec 12, 2024Radiology |
| uDR 780i510(k)Nov 1, 2024Radiology |
| uDR 380i Pro510(k)Oct 10, 2024Radiology |
| uMI Panorama510(k)Aug 30, 2024Radiology |
| uMI Panvivo510(k)Aug 15, 2024Radiology |
| uPMR 790510(k)May 24, 2024Radiology |
| uOmnispace.CT510(k)May 17, 2024Radiology |
| uMR Jupiter510(k)Apr 26, 2024Radiology |
| uOmnispace.MR510(k)Apr 17, 2024Radiology |
| uMR 680510(k)Apr 10, 2024Radiology |
| uMR Omega510(k)Mar 22, 2024Radiology |
| uEXPLORER510(k)Jan 18, 2024Radiology |
| uOmnispace.MI510(k)Dec 20, 2023Radiology |
| uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis510(k)Nov 29, 2023Radiology |
| uMI Panorama510(k)Oct 3, 2023Radiology |
| uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis510(k)Aug 1, 2023Radiology |
| uMI Panorama510(k)Jul 26, 2023Radiology |
| uOmnispace510(k)Jul 20, 2023Radiology |
| uMR Omega510(k)May 23, 2023Radiology |
| uMR 570510(k)May 18, 2023Radiology |
| uMI Panorama510(k)Mar 10, 2023Radiology |
| uCT ATLAS Astound with uWS-CT-Dual Energy Analysis510(k)Feb 16, 2023Radiology |
| uPMR 790510(k)Nov 14, 2022Radiology |
| uMR Omega with uWS-MR-MRS510(k)Oct 27, 2022Radiology |
| uDR 380i Pro510(k)Sep 30, 2022Radiology |
| uCT ATLAS with uWS-CT-Dual Energy Analysis510(k)Aug 11, 2021Radiology |
| HYPER AiR510(k)Apr 30, 2021Radiology |
| HYPER Focus510(k)Apr 9, 2021Radiology |