Siemens Healthcare GmbH - FDA 510(k) Cleared Devices

Siemens Healthcare GmbH has 30 FDA 510(k) cleared radiology devices. Based in Erlangen, DE.

Latest FDA clearance: Apr 2026. Active since 2016.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Regulatory Technology Services, LLC, Tuv Sud America, Inc. and Siemens Medical Solutions USA, Inc.. 2 submissions have an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.