Samsung Medison 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 Samsung Medison Co., Ltd. has 18. The gap is 15 devices. They overlap on Radiology (18 vs 33). The newer decision is uMR Astra from Shanghai United Imaging Healthcare Co., Ltd. on May 22, 2026. The latest from Samsung Medison Co., Ltd. is HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System on January 5, 2026.
| Samsung Medison | Shanghai United Imaging Healthcare | |
|---|---|---|
| AI devices | 18 | 33 |
| Share of the FDA AI list | 1.1% | 2% |
| First decision | May 13, 2021 | May 5, 2020 |
| Latest decision | January 5, 2026 | May 22, 2026 |
| Specialties | 1 | 1 |
| Largest specialty | Radiology (18) | Radiology (33) |
| Top product code | IYN (18) | LNH (10) |
| 510(k) | 18 | 33 |
| De Novo | 0 | 0 |
| PMA | 0 | 0 |
| Dated 2026 | 1 | 5 |
Year by year
| Year | Samsung Medison | Shanghai United Imaging Healthcare |
|---|---|---|
| 2026 | 1 | 5 |
| 2025 | 2 | 10 |
| 2024 | 5 | 7 |
| 2023 | 4 | 6 |
| 2022 | 3 | 0 |
| 2021 | 3 | 1 |
| 2020 | 0 | 4 |
Where they overlap
Latest from Samsung Medison
- HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · Radiology
- HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 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, Samsung Medison or Shanghai United Imaging Healthcare?
Shanghai United Imaging Healthcare Co., Ltd. has 33 AI-enabled devices on the FDA list, and Samsung Medison Co., Ltd. has 18. The gap is 15 devices.
Do Samsung Medison and Shanghai United Imaging Healthcare have AI devices in the same specialty?
They overlap on Radiology (18 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 Samsung Medison Co., Ltd. is HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System on January 5, 2026.
How many AI devices did each company clear in 2026?
Samsung Medison has 1 devices dated 2026, and Shanghai United Imaging Healthcare has 5.
Do they share FDA product codes?
No product code appears on both applicants' AI-device lists.
Cite as: AI Device Radar, “Samsung Medison vs Shanghai United Imaging Healthcare: FDA-cleared AI devices,” https://ai-device-radar.vercel.app/compare/samsung-medison-co-ltd/shanghai-united-imaging-healthcare-co-ltd (FDA list through 2026-06-29).