healthcare · HIPAA · FDA SaMD guidance · EU AI Act Annex III
Radiology AI (SaMD)
Radiology AI 510(k) — per-read decision receipt for malpractice
—FDA SaMD + EU MDR
Regulatory exposure — commonly overlooked:
Hospital owns read — AI vendor owns cleared device label only · Multinationals built for one jurisdiction fail exams in another — one receipt architecture, many filing packs.
TAM / Exposure
$2B AI radiology
Insurance lines
E&O · Cyber · Sector liability
Exhibit authority
Global External Validation — Radiology AI (SaMD) External Validation Pack
Global leaders
Aidoc · Google Health · FDA · ISO · NIST · OECD · UNESCO
Missed finding
AI flagged then dismissed — who owns miss? Receipt settles.
FDA PCCP
Model update without receipt = off-label use inference