Siemens Healthineers AG

Siemens Healthineers AG — FDA 510(k) Submissions

Siemens Healthineers AG has submitted 3 FDA 510(k) premarket notifications since 2025, of which 3 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Automated Radiological Image Processing Software, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance, System, Image Processing, Radiological . Use the specialty filter in the sidebar to narrow results.