# Shanghai United Imaging Healthcare Co., Ltd.

- Location (FDA's records): Shanghai, CN
- FDA decisions: 85 (2018–2026): 85 510(k) clearances
- Product codes: LNH (22), KPS (18), JAK (12), LLZ (11), KPR (6), QIH (6), OUO (4), OWB (3), IZL (2), MOS (1)
- 510(k) review time since 2016: median 133 days, against 121 for FDA's reviews in the same codes and years (30 of 81 faster)
- Predicates its devices cite: 101 (69 its own); citations of its devices by later devices: 73 (69 its own)
- Recalls linked to its devices: 42 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Siemens Medical Solutions USA, Inc.: 10 (https://510kreport.com/company/siemens-medical-solutions-usa)
- GE Medical Systems: 3 (https://510kreport.com/company/ge-medical-systems)
- Siemens AG Medical Solutions: 3 (https://510kreport.com/company/siemens-ag-medical-solutions)
- Siemens Healthcare GmbH: 2 (https://510kreport.com/company/siemens-healthcare)
- Quality Electrodynamics, LLC: 2 (https://510kreport.com/company/quality-electrodynamics)
- Siemens Medi Cal Solutions, Inc.: 1 (https://510kreport.com/company/siemens-medi-cal-solutions)
- Pie Medical Imaging BV: 1 (https://510kreport.com/company/pie-medical-imaging)
- Carestream Health, Inc.: 1 (https://510kreport.com/company/carestream-health)

## Firms that cite its devices most
- Shanghai United Imaging Intelligence Co., Ltd.: 2 (https://510kreport.com/company/shanghai-united-imaging-intelligence)
- Shangai United Imaging Healthcare Co., Ltd.: 1 (https://510kreport.com/company/shangai-united-imaging-healthcare)
- Xingaoyi Medical Equipment Co.,Ltd: 1 (https://510kreport.com/company/xingaoyi-medical-equipment)

## Its most-cited devices
- K172143: uMI 780 PET/CT System (2018), cited by 5
- K172135: uCT Computed Tomography X-ray System (2018), cited by 5
- K183170: uWS-CT (2019), cited by 3
- K203448: uCT ATLAS with uWS-CT-Dual Energy Analysis (2021), cited by 3
- K230152: uMR Omega (2023), cited by 3
- K181414: uCT 530, uCT 550 (2018), cited by 2

## Recent decisions
- K253726: uAngio AVIVA CX (Aug 21, 2026)
- K261427: uMI Panvivo (uMI Panvivo M) (Jul 28, 2026)
- K260113: uMR Astra (May 22, 2026)
- K253077: uOmnispace.MR (Apr 22, 2026)
- 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) (Apr 3, 2026)
- K253564: uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) (Feb 13, 2026)
- K253173: uCT 780 with uWS-CT-Dual Energy Analysis (Jan 20, 2026)
- K252000: uDR Arria & uDR Aris (Nov 26, 2025)

Source page: https://510kreport.com/company/shanghai-united-imaging-healthcare