Shanghai United Imaging Healthcare Co., Ltd.: FDA clearances and approvals
Shanghai United Imaging Healthcare Co., Ltd. has 85 FDA 510(k) clearances (first 2018, latest 2026), across 10 product codes in 1 review panel. Median 510(k) review time: 133 days. Since 2017 its median was 133 days, against 116 days for all cleared 510(k)s in the same product codes. openFDA lists 33 product recalls by a recalling firm named Shanghai United Imaging Healthcare Co., Ltd.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 14 | 104 |
| 2019 | 9 | 81 |
| 2020 | 10 | 148 |
| 2021 | 3 | 116 |
| 2022 | 3 | 84 |
| 2023 | 10 | 127 |
| 2024 | 12 | 118 |
| 2025 | 17 | 202 |
| 2026 | 7 | 116 |
Review time against the same product codes
Since 2017, Shanghai United Imaging Healthcare Co., Ltd.'s cleared 510(k)s took a median 133 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | 22 | 22 |
| KPS | System, Tomography, Computed, Emission | 18 | 18 |
| JAK | System, X-Ray, Tomography, Computed | 12 | 12 |
| LLZ | System, Image Processing, Radiological | 11 | 11 |
| KPR | System, X-Ray, Stationary | 6 | 6 |
| QIH | Automated Radiological Image Processing Software | 6 | 6 |
| OUO | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | 4 | 4 |
| OWB | Interventional Fluoroscopic X-Ray System | 3 | 3 |
| IZL | System, X-Ray, Mobile | 2 | 2 |
| MOS | Coil, Magnetic Resonance, Specialty | 1 | 1 |
Review panels
- Radiology (85)
Most recent Shanghai United Imaging Healthcare Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253726 | uAngio AVIVA CX | OWB | 2026-08-21 | 270 |
| K261427 | uMI Panvivo (uMI Panvivo M) | KPS | 2026-07-28 | 89 |
| K260113 | uMR Astra | LNH | 2026-05-22 | 128 |
| K253077 | uOmnispace.MR | QIH | 2026-04-22 | 211 |
| K260524 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | KPS | 2026-04-03 | 45 |
| K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | KPS | 2026-02-13 | 88 |
| K253173 | uCT 780 with uWS-CT-Dual Energy Analysis | JAK | 2026-01-20 | 116 |
| K252000 | uDR Arria & uDR Aris | KPR | 2025-11-26 | 152 |
| K252371 | uMR 680 | LNH | 2025-09-25 | 57 |
| K250045 | uWS-Angio Pro | LLZ | 2025-09-24 | 257 |
75 earlier clearances. See the full list in Caduvo.
Recalls
33 product recalls in 15 recall events; 14 initiated in the last five years. Most recent: 2026-08-11.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Shanghai United Imaging Healthcare Co., Ltd.'s product codes (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
Frequently asked questions
How many FDA 510(k) clearances does Shanghai United Imaging Healthcare Co., Ltd. have?
Shanghai United Imaging Healthcare Co., Ltd. has 85 FDA 510(k) clearances (first 2018, latest 2026), across 10 product codes in 1 review panel.
How long does FDA take to clear Shanghai United Imaging Healthcare Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Shanghai United Imaging Healthcare Co., Ltd.'s cleared 510(k)s is 133 days. Since 2017: 133 days, versus 116 days for all cleared 510(k)s in the same product codes.
What devices does Shanghai United Imaging Healthcare Co., Ltd. make?
Its most frequent FDA product codes are LNH (System, Nuclear Magnetic Resonance Imaging, 22); KPS (System, Tomography, Computed, Emission, 18); JAK (System, X-Ray, Tomography, Computed, 12).
Has Shanghai United Imaging Healthcare Co., Ltd. had device recalls?
openFDA lists 33 product recalls in 15 recall events by a recalling firm whose name matches Shanghai United Imaging Healthcare Co., Ltd; the most recent began 2026-08-11. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 85 Shanghai United Imaging Healthcare Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LNH, Shanghai United Imaging Healthcare Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.