Philips Ultrasound 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 Philips Ultrasound, LLC has 21. The gap is 12 devices. They overlap on Radiology (21 vs 33). The newer decision is Alturion Series Diagnostic Ultrasound System from Philips Ultrasound, LLC on June 29, 2026. The latest from Shanghai United Imaging Healthcare Co., Ltd. is uMR Astra on May 22, 2026.
| Philips Ultrasound | Shanghai United Imaging Healthcare | |
|---|---|---|
| AI devices | 21 | 33 |
| Share of the FDA AI list | 1.3% | 2% |
| First decision | May 12, 2023 | May 5, 2020 |
| Latest decision | June 29, 2026 | May 22, 2026 |
| Specialties | 1 | 1 |
| Largest specialty | Radiology (21) | Radiology (33) |
| Top product code | IYN (20) | LNH (10) |
| 510(k) | 21 | 33 |
| De Novo | 0 | 0 |
| PMA | 0 | 0 |
| Dated 2026 | 5 | 5 |
Year by year
| Year | Philips Ultrasound | Shanghai United Imaging Healthcare |
|---|---|---|
| 2026 | 5 | 5 |
| 2025 | 9 | 10 |
| 2024 | 5 | 7 |
| 2023 | 2 | 6 |
| 2021 | 0 | 1 |
| 2020 | 0 | 4 |
Where they overlap
Shared product codes
Latest from Philips Ultrasound
- Alturion Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- EPIQ Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsPhilips Ultrasound, LLC · Radiology
- Lumify Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · Radiology
- EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, 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, Philips Ultrasound or Shanghai United Imaging Healthcare?
Shanghai United Imaging Healthcare Co., Ltd. has 33 AI-enabled devices on the FDA list, and Philips Ultrasound, LLC has 21. The gap is 12 devices.
Do Philips Ultrasound and Shanghai United Imaging Healthcare have AI devices in the same specialty?
They overlap on Radiology (21 vs 33).
Which company has the more recent AI clearance?
The newer decision is Alturion Series Diagnostic Ultrasound System from Philips Ultrasound, LLC on June 29, 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?
Philips Ultrasound 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 QIH (1 vs 6).
Cite as: AI Device Radar, “Philips Ultrasound vs Shanghai United Imaging Healthcare: FDA-cleared AI devices,” https://ai-device-radar.vercel.app/compare/philips-ultrasound-llc/shanghai-united-imaging-healthcare-co-ltd (FDA list through 2026-06-29).