Aidoc Medical vs Shanghai United Imaging Healthcare: FDA-cleared AI devices
Aidoc Medical, Ltd. has 35 AI-enabled devices on the FDA list, and Shanghai United Imaging Healthcare Co., Ltd. has 33. The gap is 2 devices. They overlap on Radiology (35 vs 33). The newer decision is uMR Astra from Shanghai United Imaging Healthcare Co., Ltd. on May 22, 2026. The latest from Aidoc Medical, Ltd. is BriefCase-Triage on May 14, 2026.
| Aidoc Medical | Shanghai United Imaging Healthcare | |
|---|---|---|
| AI devices | 35 | 33 |
| Share of the FDA AI list | 2.2% | 2% |
| First decision | August 1, 2018 | May 5, 2020 |
| Latest decision | May 14, 2026 | May 22, 2026 |
| Specialties | 1 | 1 |
| Largest specialty | Radiology (35) | Radiology (33) |
| Top product code | QAS (25) | LNH (10) |
| 510(k) | 35 | 33 |
| De Novo | 0 | 0 |
| PMA | 0 | 0 |
| Dated 2026 | 4 | 5 |
Year by year
| Year | Aidoc Medical | Shanghai United Imaging Healthcare |
|---|---|---|
| 2026 | 4 | 5 |
| 2025 | 3 | 10 |
| 2024 | 5 | 7 |
| 2023 | 5 | 6 |
| 2022 | 10 | 0 |
| 2021 | 1 | 1 |
| 2020 | 3 | 4 |
| 2019 | 3 | 0 |
| 2018 | 1 | 0 |
Where they overlap
Shared product codes
Latest from Aidoc Medical
- BriefCase-TriageAidoc Medical , Ltd. · Radiology
- BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation deviceAidoc Medical , Ltd. · Radiology
- BriefCase-TriageAidoc Medical , Ltd. · Radiology
- BriefCase-Triage: CARE Multi-triage CT BodyAidoc Medical , Ltd. · Radiology
- BriefCase-TriageAidoc Medical , 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, Aidoc Medical or Shanghai United Imaging Healthcare?
Aidoc Medical, Ltd. has 35 AI-enabled devices on the FDA list, and Shanghai United Imaging Healthcare Co., Ltd. has 33. The gap is 2 devices.
Do Aidoc Medical and Shanghai United Imaging Healthcare have AI devices in the same specialty?
They overlap on Radiology (35 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 Aidoc Medical, Ltd. is BriefCase-Triage on May 14, 2026.
How many AI devices did each company clear in 2026?
Aidoc Medical 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 QIH (4 vs 6), JAK (1 vs 6).
Cite as: AI Device Radar, “Aidoc Medical vs Shanghai United Imaging Healthcare: FDA-cleared AI devices,” https://ai-device-radar.vercel.app/compare/aidoc-medical-ltd/shanghai-united-imaging-healthcare-co-ltd (FDA list through 2026-06-29).