Pharmaceutical company. FDA files no records under this name; these are its 3 companies' records, each linked to the record.
As of Nov 13, 2026, FDA's public records list United Imaging and its 3 subsidiaries with 92 510(k) clearances, 45 AI-enabled devices and 33 device recalls. The most recent is a 510(k) clearance dated Oct 28, 2026: uPMR Zenith.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, United Imaging and its 3 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 28, 2026 | uPMR ZenithK261676 · OUO | 510(k) clearances |
| Aug 21, 2026 | uAngio AVIVA CXK253726 · OWB | 510(k) clearances |
| Aug 11, 2026 | Computed Tomography X-ray System, Model: uCT 530 with softwareClass II · Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function | Device recalls |
| Aug 11, 2026 | Computed Tomography X-ray System, Model: uCT 550 with softwareClass II · Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function | Device recalls |
| Aug 11, 2026 | Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with softwareClass II · Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function | Device recalls |
| Aug 11, 2026 | Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with softwareClass II · Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function | Device recalls |
| Aug 11, 2026 | Computed Tomography X-ray System, Model: uCT 780 with softwareClass II · Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function | Device recalls |
| Aug 11, 2026 | Computed Tomography X-ray System, Model: uCT ATLAS with softwareClass II · Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function | Device recalls |
| Aug 11, 2026 | Computed Tomography X-ray System, Model: uCT ATLAS Astound with softwareClass II · Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function | Device recalls |
| Aug 11, 2026 | Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with softwareClass II · Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function | Device recalls |
| Jul 28, 2026 | uMI Panvivo (uMI Panvivo M)K261427 · KPS | 510(k) clearances |
| May 22, 2026 | uMR AstraK260113 · LNH | 510(k) clearances |
| May 22, 2026 | uMR AstraK260113 · Radiology | AI-enabled devices |
| May 21, 2026 | uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace EliteK253720 · IYN | 510(k) clearances |
| May 21, 2026 | uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace EliteK253720 · Radiology | AI-enabled devices |
| May 15, 2026 | uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus SuperK253716 · IYN | 510(k) clearances |
| May 15, 2026 | uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus SuperK253716 · Radiology | AI-enabled devices |
| Apr 22, 2026 | uOmnispace.MRK253077 · QIH | 510(k) clearances |
| Apr 22, 2026 | uOmnispace.MRK253077 · Radiology | AI-enabled devices |
| Apr 3, 2026 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)K260524 · KPS | 510(k) clearances |
| Apr 3, 2026 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)K260524 · Radiology | AI-enabled devices |
| Feb 13, 2026 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)K253564 · Radiology | AI-enabled devices |
| Jan 20, 2026 | uCT 780 with uWS-CT-Dual Energy AnalysisK253173 · Radiology | AI-enabled devices |
| Sep 25, 2025 | uMR 680K252371 · Radiology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
