Summary
Classifies radiological machine learning-based quantitative imaging software with a predetermined change control plan as class II and establishes special controls under 21 CFR 892.2055. The device provides quantitative imaging outputs, including functions such as view selection, segmentation and landmarking. Controls address validation, training and test data, planned modifications, risk management and labeling.
Healthcare Implications
Establishes enforceable special controls for this category of AI-enabled quantitative imaging software, including validation and risk controls for modifications under a predetermined change control plan.