BunkerHill Health

BunkerHill Health — FDA 510(k) Submissions

BunkerHill Health has submitted 8 FDA 510(k) premarket notifications since 2024, of which 8 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, X-ray, Tomography, Computed, Densitometer, Bone, Automated Radiological Image Processing Software, Reduced Ejection Fraction Machine Learning-based Notification Software . Use the specialty filter in the sidebar to narrow results.