Canon Medical Systems vs Shanghai United Imaging Healthcare: FDA-cleared AI devices
Canon Medical Systems Corporation has 42 AI-enabled devices on the FDA list, and Shanghai United Imaging Healthcare Co., Ltd. has 33. The gap is 9 devices. They overlap on Radiology (42 vs 33). The newer decision is uMR Astra from Shanghai United Imaging Healthcare Co., Ltd. on May 22, 2026. The latest from Canon Medical Systems Corporation is Aquilion ONE (TSX-308A/TSX-306A) V2.0 on May 20, 2026.
| Canon Medical Systems | Shanghai United Imaging Healthcare | |
|---|---|---|
| AI devices | 42 | 33 |
| Share of the FDA AI list | 2.6% | 2% |
| First decision | June 12, 2019 | May 5, 2020 |
| Latest decision | May 20, 2026 | May 22, 2026 |
| Specialties | 1 | 1 |
| Largest specialty | Radiology (42) | Radiology (33) |
| Top product code | JAK (18) | LNH (10) |
| 510(k) | 42 | 33 |
| De Novo | 0 | 0 |
| PMA | 0 | 0 |
| Dated 2026 | 4 | 5 |
Year by year
| Year | Canon Medical Systems | Shanghai United Imaging Healthcare |
|---|---|---|
| 2026 | 4 | 5 |
| 2025 | 6 | 10 |
| 2024 | 6 | 7 |
| 2023 | 7 | 6 |
| 2022 | 5 | 0 |
| 2021 | 7 | 1 |
| 2020 | 5 | 4 |
| 2019 | 2 | 0 |
Where they overlap
Shared product codes
JAKSystem, X-Ray, Tomography, Computed18 / 6LNHSystem, Nuclear Magnetic Resonance Imaging12 / 10KPSSystem, Tomography, Computed, Emission3 / 8QIHAutomated Radiological Image Processing Software1 / 6Latest from Canon Medical Systems
- Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation · Radiology
- Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MRCanon Medical Systems Corporation · Radiology
- Aquilion ServeSP (TSX-307B) V2.0Canon Medical Systems Corporation · Radiology
- Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)Canon Medical Systems Corporation · Radiology
- Cartesion Prime (PCD-1000A/3) V10.21Canon Medical Systems Corporation · 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, Canon Medical Systems or Shanghai United Imaging Healthcare?
Canon Medical Systems Corporation has 42 AI-enabled devices on the FDA list, and Shanghai United Imaging Healthcare Co., Ltd. has 33. The gap is 9 devices.
Do Canon Medical Systems and Shanghai United Imaging Healthcare have AI devices in the same specialty?
They overlap on Radiology (42 vs 33).
Which company has the more recent AI clearance?
The newer decision is uMR Astra from Shanghai United Imaging Healthcare Co., Ltd. on May 22, 2026. The latest from Canon Medical Systems Corporation is Aquilion ONE (TSX-308A/TSX-306A) V2.0 on May 20, 2026.
How many AI devices did each company clear in 2026?
Canon Medical Systems has 4 devices dated 2026, and Shanghai United Imaging Healthcare has 5.
Do they share FDA product codes?
Yes. The codes on both lists include JAK (18 vs 6), LNH (12 vs 10), KPS (3 vs 8), QIH (1 vs 6).
Cite as: AI Device Radar, “Canon Medical Systems vs Shanghai United Imaging Healthcare: FDA-cleared AI devices,” https://ai-device-radar.vercel.app/compare/canon-medical-systems-corporation/shanghai-united-imaging-healthcare-co-ltd (FDA list through 2026-06-29).