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# GE Healthcare has 93 FDA-authorised AI devices, the most of any company, ahead of Siemens Healthineers' 82
- URL: https://aiadoption.org/data/fda-ai-medical-devices-by-company/
- Published: 2026-10-19T16:36:22.000Z
- Updated: 2026-10-21T06:05:00.000Z
- Description: GE Healthcare holds 93 FDA-authorised AI-enabled medical devices and Siemens Healthineers 82, more than twice the next company, Shanghai United Imaging Healthcare (38).
- Author: Manu
- Tags: Data, AI in Healthcare, AI in the US, #chart, #ai-index-2026, #hub-healthcare, #country-us

93

#1

AI-enabled devices authorised by the FDA for GE Healthcare, the most of any company; Siemens Healthineers has 82

Devices authorised

GE Healthcare93

Siemens Healthineers82

United Imaging Healthcare38

## What the chart shows

Large imaging manufacturers hold the most FDA-authorised AI-enabled devices. GE Healthcare has 93 and Siemens Healthineers 82, more than twice the next companies: Shanghai United Imaging Healthcare (38), Philips Healthcare (36) and Canon Medical Systems (35).

Aidoc Medical (30) is next. The 15 companies shown hold 424 devices between them, under a third of the 1,357 on the FDA’s list; the AI Index says most companies with an authorised device hold only one or two.

## Key numbers

| Measure                            | Value |
| ---------------------------------- | ----- |
| GE Healthcare                      | 93    |
| Siemens Healthineers               | 82    |
| Shanghai United Imaging Healthcare | 38    |
| Philips Healthcare                 | 36    |
| Canon Medical Systems              | 35    |
| Aidoc Medical                      | 30    |

## How to read it

- Counts by company name as listed by the FDA; related companies may be listed separately.
- The AI Index text gives the number of companies with at least one device as 626 in one place and 693 in another; the data covers only these 15.
- Authorised covers every route on the FDA’s list, mostly 510(k) clearance; the AI Index’s chart title says ‘approved’.

**Source:** [FDA](https://aiadoption.org/sources/#fda-ai-devices), 2025, via the AI Index Report 2026 (Stanford HAI), figure 6.2.9: *Number of AI/ML medical devices approved by the FDA by top companies, 2016–25*. Chart and text by AI Adoption.  
Numbers checked against the published data on 20 October 2026.  
[Download the data (CSV)](https://charts.aiadoption.org/ai-index/csv/fda-ai-medical-devices-by-company.csv?ref=aiadoption.org) · [Cite this chart](#source)