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

MeasureValue
All imaging devices cleared, 2025246
All imaging devices cleared, 2024222
All imaging devices cleared, 201616
Radiology, 2025198
Cardiovascular, 202520
Neurology, 202515

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, 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.
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