Transparency Registry · applicant
Shanghai United Imaging Healthcare Co., Ltd.: 6 FDA AI clearances
Every 510(k) clearance held by Shanghai United Imaging Healthcare Co., Ltd. under the AI-associated product codes this registry tracks, from openFDA public records, refreshed weekly. Facts only; listing is not evaluation.
| Device | Decision date | Category |
|---|---|---|
| uOmnispace.MR | 2026-04-22 | QIH |
| Medical Image Post-processing Software (uOmnispace.CT) | 2025-05-14 | QIH |
| uOmnispace.CT | 2024-05-17 | QIH |
| uOmnispace.MR | 2024-04-17 | QIH |
| uOmnispace | 2023-07-20 | QIH |
| uWS-MR | 2020-06-01 | QIH |
Sources linked on each entry. Coverage note: this lists clearances under tracked AI-associated codes only — the company may hold other clearances outside them. Work for Shanghai United Imaging Healthcare Co., Ltd.? The disclosure rows on your entries update free on submission of public links — start here.
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