The FDA's regulatory list now includes over 1,300 AI-enabled medical devices, with radiology comprising the largest share, signaling accelerated clinical adoption of AI in imaging. Real-world screening trials demonstrate AI can reduce mammography reading workload by 44% while maintaining cancer detection rates, and the UK has launched an AI breast-screening trial across 700,000 women. This marks a critical shift in diagnostic capacity and access, particularly for regions facing radiologist shortages, raising urgent questions about clinical risk ownership and integration infrastructure as AI triages scans at population scale.