Shanghai United Imaging Healthcare vs Siemens Medical Solutions USA: FDA-cleared AI devices
Siemens Medical Solutions USA, Inc. has 67 AI-enabled devices on the FDA list, and Shanghai United Imaging Healthcare Co., Ltd. has 33. The gap is 34 devices. They overlap on Radiology (33 vs 67). The newer decision is syngo.CT Coronary Cockpit from Siemens Medical Solutions USA, Inc. on June 25, 2026. The latest from Shanghai United Imaging Healthcare Co., Ltd. is uMR Astra on May 22, 2026.
| Shanghai United Imaging Healthcare | Siemens Medical Solutions USA | |
|---|---|---|
| AI devices | 33 | 67 |
| Share of the FDA AI list | 2% | 4.2% |
| First decision | May 5, 2020 | January 24, 2014 |
| Latest decision | May 22, 2026 | June 25, 2026 |
| Specialties | 1 | 1 |
| Largest specialty | Radiology (33) | Radiology (67) |
| Top product code | LNH (10) | LNH (17) |
| 510(k) | 33 | 66 |
| De Novo | 0 | 0 |
| PMA | 0 | 1 |
| Dated 2026 | 5 | 5 |
Year by year
| Year | Shanghai United Imaging Healthcare | Siemens Medical Solutions USA |
|---|---|---|
| 2026 | 5 | 5 |
| 2025 | 10 | 4 |
| 2024 | 7 | 12 |
| 2023 | 6 | 10 |
| 2022 | 0 | 15 |
| 2021 | 1 | 5 |
| 2020 | 4 | 9 |
| 2019 | 0 | 5 |
| 2017 | 0 | 1 |
| 2014 | 0 | 1 |
Where they overlap
Shared product codes
LNHSystem, Nuclear Magnetic Resonance Imaging10 / 17JAKSystem, X-Ray, Tomography, Computed6 / 14QIHAutomated Radiological Image Processing Software6 / 12KPSSystem, Tomography, Computed, Emission8 / 3LLZSystem, Image Processing, Radiological1 / 4KPRSystem, X-Ray, Stationary1 / 1Latest from Shanghai United Imaging Healthcare
- uMR AstraShanghai United Imaging Healthcare Co., Ltd. · Radiology
- uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd. · Radiology
- uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd. · Radiology
- uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd. · Radiology
- uCT 780 with uWS-CT-Dual Energy AnalysisShanghai United Imaging Healthcare Co., Ltd. · Radiology
Latest from Siemens Medical Solutions USA
- syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc. · Radiology
- ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · Radiology
- syngo Application SoftwareSiemens Medical Solutions USA, Inc. · Radiology
- SOMATOM X.cite; SOMATOM X.ceedSiemens Medical Solutions USA, Inc. · Radiology
- MI View&GOSiemens Medical Solutions USA, Inc. · Radiology
More comparisons
Frequently asked questions
Who has more FDA-cleared AI devices, Shanghai United Imaging Healthcare or Siemens Medical Solutions USA?
Siemens Medical Solutions USA, Inc. has 67 AI-enabled devices on the FDA list, and Shanghai United Imaging Healthcare Co., Ltd. has 33. The gap is 34 devices.
Do Shanghai United Imaging Healthcare and Siemens Medical Solutions USA have AI devices in the same specialty?
They overlap on Radiology (33 vs 67).
Which company has the more recent AI clearance?
The newer decision is syngo.CT Coronary Cockpit from Siemens Medical Solutions USA, Inc. on June 25, 2026. The latest from Shanghai United Imaging Healthcare Co., Ltd. is uMR Astra on May 22, 2026.
How many AI devices did each company clear in 2026?
Shanghai United Imaging Healthcare has 5 devices dated 2026, and Siemens Medical Solutions USA has 5.
Do they share FDA product codes?
Yes. The codes on both lists include LNH (10 vs 17), JAK (6 vs 14), QIH (6 vs 12), KPS (8 vs 3).
Cite as: AI Device Radar, “Shanghai United Imaging Healthcare vs Siemens Medical Solutions USA: FDA-cleared AI devices,” https://ai-device-radar.vercel.app/compare/shanghai-united-imaging-healthcare-co-ltd/siemens-medical-solutions-usa-inc (FDA list through 2026-06-29).