Is AI-based radiology software FDA approved?

Many AI radiology tools on the U.S. market have received FDA clearance, most commonly through the 510(k) pathway for moderate-risk devices, rather than full FDA "approval," which is a separate and generally more rigorous process. Clearance status varies by product and by the specific clinical use the software is cleared for, so it is worth checking a vendor's specific clearance rather than assuming clearance for one use extends to another. See FDA Clearance (510(k)).