> ## Content Index
> Fetch the complete content index at: https://aiadoption.org/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA 510(k) clearances of AI imaging devices reached 246 in 2025; radiology accounted for 198
- URL: https://aiadoption.org/data/fda-510k-ai-imaging-devices/
- Published: 2026-10-19T16:36:32.000Z
- Updated: 2026-10-21T06:04:58.000Z
- Description: The FDA cleared 246 AI-enabled imaging devices through its 510(k) pathway in 2025, up from 222 in 2024 and 16 in 2016. Radiology accounted for 198, or 80%.
- Author: Manu
- Tags: Data, AI in Healthcare, AI in the US, #chart, #ai-index-2026, #hub-healthcare, #country-us

246

▲ 11% vs 2024

AI-enabled imaging devices cleared through the FDA's 510(k) pathway in 2025

20112025

## What the chart shows

The 510(k) pathway lets a device reach the US market by showing it is substantially equivalent to one already on sale, without new clinical trials. The FDA cleared 246 AI- or machine-learning-enabled imaging devices this way in 2025, up 11% from 222 in 2024 and from 16 in 2016.

Radiology accounted for 198 of the 2025 clearances (80%), cardiovascular devices for 20 and neurology for 15\. The AI Index notes that clearance does not equal clinical adoption.

## Key numbers

| Measure                           | Value |
| --------------------------------- | ----- |
| All imaging devices cleared, 2025 | 246   |
| All imaging devices cleared, 2024 | 222   |
| All imaging devices cleared, 2016 | 16    |
| Radiology, 2025                   | 198   |
| Cardiovascular, 2025              | 20    |
| Neurology, 2025                   | 15    |

## How to read it

- 510(k) clearance is not FDA approval, which is a separate route (premarket approval). Counts are clearances as the FDA’s data defines them.
- Imaging-related devices only. Other combines ophthalmic, orthopaedic and pathology devices (7 in 2025).

**Source:** [FDA](https://aiadoption.org/sources/#fda-ai-devices), 2025, via the AI Index Report 2026 (Stanford HAI), figure 6.2.5: *FDA 510(k)-cleared AI/ML-enabled imaging-related medical devices, 2011–25*. 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-510k-ai-imaging-devices.csv?ref=aiadoption.org) · [Cite this chart](#source)