Data / Medical devices / United States / United Imaging Healthcare North America, Inc
United Imaging Healthcare North America, Inc: FDA-registered device maker in Houston, TX, United States, 37 510(k) clearances
United Imaging Healthcare North America, Inc is registered with the FDA (registration 3011950073) in Houston, TX, United States. It lists 11 device types. The FDA files 37 510(k) clearances under its listings, the newest dated February 13, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011950073
- Address
- 9230 Kirby Drive, Suite 600, Houston, TX, United States, 77054
- Owner or operator
- United Imaging Healthcare North America, Inc (10059541)
- Roles
- Complaint file establishment
- First device listed
- March 19, 2026
- Registered through
- 2027
- Brand names listed
- uEXPLORER, uPMR 790
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 13, 2026 | K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | KPS | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| January 20, 2026 | K253173 | uCT 780 with uWS-CT-Dual Energy Analysis | JAK | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| November 26, 2025 | K252000 | uDR Arria & uDR Aris | KPR | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| September 25, 2025 | K252371 | uMR 680 | LNH | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| September 19, 2025 | K251167 | uDR Aurora CX | KPR | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| August 5, 2025 | K250246 | uMR Jupiter | LNH | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| July 17, 2025 | K251839 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | KPS | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| July 17, 2025 | K243547 | uMR Ultra | LNH | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| July 16, 2025 | K243397 | uMR 680 | LNH | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| May 21, 2025 | K243122 | uMR Omega | LNH | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| May 16, 2025 | K243617 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis | JAK | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| April 28, 2025 | K243376 | uAngio AVIVA CX | OWB | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| January 14, 2025 | K241166 | uCT 550 | JAK | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| January 7, 2025 | K241079 | uCT 780 | JAK | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| December 12, 2024 | K243538 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | KPS | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| November 1, 2024 | K241068 | uDR 780i | KPR | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| October 10, 2024 | K242515 | uDR 380i Pro | IZL | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| August 30, 2024 | K241585 | uMI Panorama | KPS | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| August 15, 2024 | K241596 | uMI Panvivo | KPS | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| May 24, 2024 | K234154 | uPMR 790 | OUO | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| April 10, 2024 | K240744 | uMR 680 | LNH | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| January 18, 2024 | K231762 | uEXPLORER | KPS | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| November 29, 2023 | K231482 | uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis | JAK | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| October 3, 2023 | K232712 | uMI Panorama | KPS | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| August 1, 2023 | K230162 | uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis | JAK | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| July 26, 2023 | K231572 | uMI Panorama | KPS | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| May 23, 2023 | K230152 | uMR Omega | LNH | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| March 10, 2023 | K223325 | uMI Panorama | KPS | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| February 16, 2023 | K222755 | uMR 680 | LNH | Substantially Equivalent | Shanghai United Imaging Intelligence Co., Ltd. | accessdata.fda.gov |
| March 27, 2020 | K193200 | uMR Omega | LNH | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| February 25, 2020 | K200016 | uCT 530, uCT 550 | JAK | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| January 26, 2020 | K193241 | Emission Computed Tomography System | KPS | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| November 20, 2019 | K192672 | uPMR 790 | OUO | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| September 12, 2019 | K192293 | uDR 592h, uDR 596i | KPR | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| December 18, 2018 | K182938 | Emission Computed Tomography System | KPS | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| October 12, 2018 | K182237 | uMI 550 PET/CT System | KPS | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
| January 26, 2018 | K173953 | uDR 780i | KPR | Substantially Equivalent | Shanghai United Imaging Healthcare Co., Ltd. | accessdata.fda.gov |
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Updated February 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.