Ge Medical Systems vs Shanghai United Imaging Healthcare: FDA-cleared AI devices
Shanghai United Imaging Healthcare Co., Ltd. has 33 AI-enabled devices on the FDA list, and Ge Medical Systems, LLC has 24. The gap is 9 devices. They overlap on Radiology (24 vs 33). The newer decision is Enhanced Boundary for PCCT from Ge Medical Systems, LLC on June 24, 2026. The latest from Shanghai United Imaging Healthcare Co., Ltd. is uMR Astra on May 22, 2026.
| Ge Medical Systems | Shanghai United Imaging Healthcare | |
|---|---|---|
| AI devices | 24 | 33 |
| Share of the FDA AI list | 1.5% | 2% |
| First decision | January 18, 2019 | May 5, 2020 |
| Latest decision | June 24, 2026 | May 22, 2026 |
| Specialties | 1 | 1 |
| Largest specialty | Radiology (24) | Radiology (33) |
| Top product code | LNH (10) | LNH (10) |
| 510(k) | 24 | 33 |
| De Novo | 0 | 0 |
| PMA | 0 | 0 |
| Dated 2026 | 5 | 5 |
Year by year
| Year | Ge Medical Systems | Shanghai United Imaging Healthcare |
|---|---|---|
| 2026 | 5 | 5 |
| 2025 | 5 | 10 |
| 2024 | 1 | 7 |
| 2023 | 3 | 6 |
| 2022 | 1 | 0 |
| 2021 | 4 | 1 |
| 2020 | 2 | 4 |
| 2019 | 3 | 0 |
Where they overlap
Shared product codes
LNHSystem, Nuclear Magnetic Resonance Imaging10 / 10JAKSystem, X-Ray, Tomography, Computed8 / 6KPSSystem, Tomography, Computed, Emission1 / 8QIHAutomated Radiological Image Processing Software2 / 6Latest from Ge Medical Systems
- Enhanced Boundary for PCCTGe Medical Systems, LLC · Radiology
- Critical Care Suite with Enteric Tube Positioning AI AlgorithmGe Medical Systems, LLC · Radiology
- Photonova Spectra, Photonova Spectra SelectGe Medical Systems, LLC · Radiology
- SIGNA BoltGe Medical Systems, LLC · Radiology
- SIGNA Sprint SelectGe Medical Systems, LLC · Radiology
Latest 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
More comparisons
Frequently asked questions
Who has more FDA-cleared AI devices, Ge Medical Systems or Shanghai United Imaging Healthcare?
Shanghai United Imaging Healthcare Co., Ltd. has 33 AI-enabled devices on the FDA list, and Ge Medical Systems, LLC has 24. The gap is 9 devices.
Do Ge Medical Systems and Shanghai United Imaging Healthcare have AI devices in the same specialty?
They overlap on Radiology (24 vs 33).
Which company has the more recent AI clearance?
The newer decision is Enhanced Boundary for PCCT from Ge Medical Systems, LLC on June 24, 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?
Ge Medical Systems has 5 devices dated 2026, and Shanghai United Imaging Healthcare has 5.
Do they share FDA product codes?
Yes. The codes on both lists include LNH (10 vs 10), JAK (8 vs 6), KPS (1 vs 8), QIH (2 vs 6).
Cite as: AI Device Radar, “Ge Medical Systems vs Shanghai United Imaging Healthcare: FDA-cleared AI devices,” https://ai-device-radar.vercel.app/compare/ge-medical-systems-llc/shanghai-united-imaging-healthcare-co-ltd (FDA list through 2026-06-29).