FDA's device list keeps radiology at the center of regulated medical AI

The authorization record offers a concrete adoption signal—and a reminder that marketing authorization is narrower than broad clinical effectiveness.

Source: U.S. Food and Drug AdministrationSource date: Mar 30, 20266 min

Key factThe FDA list identifies authorized AI-enabled devices and links each entry to its public regulatory record.

What happened

The current list continues to add radiology-led devices across imaging workflows.

FDA is exploring clearer identification of foundation-model and multimodal functionality.

Regulatory records are stronger adoption evidence than a product announcement.

Each device still needs interpretation within its specific intended use and evidence package.

FDA provides decision dates, submission numbers, companies, panels, and product codes.

FDA says the list is not comprehensive.
Authorization does not mean a device improves every clinical outcome or generalizes to every population.

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