Shanghai United Imaging Healthcare Co., Ltd.: FDA filings under this applicant name
FDA lists 85 510(k) clearances under the applicant name “Shanghai United Imaging Healthcare Co., Ltd.” (first 2018, latest 2026), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 133 days. Since 2017 the median was 133 days, against 116 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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, 510(k)s cleared under the name Shanghai United Imaging Healthcare Co., Ltd. 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 applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Shanghai United Imaging Healthcare Co., Ltd. (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)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Shanghai AnQing Medical Instrument Co., Ltd. (14 510(k)s)
- Shanghai Antares Industries, Inc. (14 510(k)s)
- Shanghai Apolo Medical Technology Co., Ltd. (14 510(k)s)
- Shanghai Palomar Mountain Industries, Inc. (12 510(k)s)
- Shanghai Sanyou Medical Co, Ltd. (9 510(k)s)
- Shanghai Chenguang Medical Technologies Co, Ltd. (8 510(k)s)
- Shanghai Motex Healthcare Co., Ltd. (8 510(k)s)
- Shanghai Poseidon Plastic Products Co., Ltd. (8 510(k)s)
- Shanghai Champion Plastic Products Co., Ltd. (6 510(k)s)
- Shanghai PT Plastics Enterprise Company, Ltd. (6 510(k)s)
- Shanghai SeeGen Photoelectric Technology Co., Ltd. (6 510(k)s)
- Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shanghai United Imaging Healthcare Co., Ltd.?
FDA lists 85 510(k) clearances under the applicant name “Shanghai United Imaging Healthcare Co., Ltd.” (first 2018, latest 2026), across 10 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Shanghai United Imaging Healthcare Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shanghai United Imaging Healthcare Co., Ltd. is 133 days. Since 2017: 133 days, versus 116 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shanghai United Imaging Healthcare Co., Ltd.?
The most frequent FDA product codes under this applicant name are LNH (System, Nuclear Magnetic Resonance Imaging, 22); KPS (System, Tomography, Computed, Emission, 18); JAK (System, X-Ray, Tomography, Computed, 12).
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. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.