Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in ChinaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of United Imaging. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Shanghai United Imaging Intelligence Co., Ltd. with 4 510(k) clearances and 4 AI-enabled devices. The most recent is a 510(k) clearance dated Sep 24, 2024: uAI Easy Triage ICH.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 24, 2024 | uAI Easy Triage ICHK242292 · QAS | 510(k) clearances |
| Sep 24, 2024 | uAI Easy Triage ICHK242292 · Radiology | AI-enabled devices |
| Sep 6, 2024 | uAI PortalK240411 · QIH | 510(k) clearances |
| Sep 6, 2024 | uAI PortalK240411 · Radiology | AI-enabled devices |
| Feb 16, 2023 | uMR 680K222755 · LNH | 510(k) clearances |
| Feb 16, 2023 | uMR 680K222755 · Radiology | AI-enabled devices |
| Jan 15, 2021 | uAI EasyTriage-RibK193271 · QFM | 510(k) clearances |
| Jan 15, 2021 | uAI EasyTriage-RibK193271 · 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
