Skip to the page

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.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 13, 2026K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)KPSSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
January 20, 2026K253173uCT 780 with uWS-CT-Dual Energy AnalysisJAKSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
November 26, 2025K252000uDR Arria & uDR ArisKPRSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
September 25, 2025K252371uMR 680LNHSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
September 19, 2025K251167uDR Aurora CXKPRSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
August 5, 2025K250246uMR JupiterLNHSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
July 17, 2025K251839uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)KPSSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
July 17, 2025K243547uMR UltraLNHSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
July 16, 2025K243397uMR 680LNHSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
May 21, 2025K243122uMR OmegaLNHSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
May 16, 2025K243617uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy AnalysisJAKSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
April 28, 2025K243376uAngio AVIVA CXOWBSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
January 14, 2025K241166uCT 550JAKSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
January 7, 2025K241079uCT 780JAKSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
December 12, 2024K243538uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)KPSSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
November 1, 2024K241068uDR 780iKPRSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
October 10, 2024K242515uDR 380i ProIZLSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
August 30, 2024K241585uMI PanoramaKPSSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
August 15, 2024K241596uMI PanvivoKPSSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
May 24, 2024K234154uPMR 790OUOSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
April 10, 2024K240744uMR 680LNHSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
January 18, 2024K231762uEXPLORERKPSSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
November 29, 2023K231482uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy AnalysisJAKSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
October 3, 2023K232712uMI PanoramaKPSSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
August 1, 2023K230162uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy AnalysisJAKSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
July 26, 2023K231572uMI PanoramaKPSSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
May 23, 2023K230152uMR OmegaLNHSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
March 10, 2023K223325uMI PanoramaKPSSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
February 16, 2023K222755uMR 680LNHSubstantially EquivalentShanghai United Imaging Intelligence Co., Ltd.accessdata.fda.gov
March 27, 2020K193200uMR OmegaLNHSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
February 25, 2020K200016uCT 530, uCT 550JAKSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
January 26, 2020K193241Emission Computed Tomography SystemKPSSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
November 20, 2019K192672uPMR 790OUOSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
September 12, 2019K192293uDR 592h, uDR 596iKPRSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
December 18, 2018K182938Emission Computed Tomography SystemKPSSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
October 12, 2018K182237uMI 550 PET/CT SystemKPSSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov
January 26, 2018K173953uDR 780iKPRSubstantially EquivalentShanghai United Imaging Healthcare Co., Ltd.accessdata.fda.gov

Compare with other makers

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.