Tempus AI, Inc.

Tempus AI, Inc. — FDA 510(k) Submissions

Tempus AI, Inc. has submitted 3 FDA 510(k) premarket notifications since 2024, of which 3 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Atrial Fibrillation Risk Prediction Machine Learning-based Notification Software, Next Generation Sequencing Based Tumor Profiling Test, Reduced Ejection Fraction Machine Learning-based Notification Software . Use the specialty filter in the sidebar to narrow results.