Is AI radiology software FDA approved?

Some AI radiology software is authorized for marketing by the FDA, but "FDA approved" is often the wrong term. Many radiology AI devices reach the U.S. market through 510(k) clearance. Others may receive De Novo authorization, while premarket approval is a different route generally used for higher-risk devices.

Check the exact product, module, version, intended use, and submission number. A company may sell several AI tools, and an FDA record for one function does not cover every product or use the company offers.

Start with the FDA's AI-Enabled Medical Device List, then open the linked database record. The FDA states that the AI list is not comprehensive, so absence from the list is not a final answer. See FDA Clearance (510(k)) and FDA-Cleared Imaging AI.