Medical Device Manufacturer · US , Hoffman Estates , IL

Siemens Medical Solutions USA, Inc. - FDA 510(k) Cleared Devices

784 submissions · 784 cleared · Since 1980

Recent clearances: syngo.CT Brain Quantification, ACUNAV Luxera 4D ICE Catheter, syngo.CT Coronary Cockpit

View 784 510(k) Devices ↓

784

Total

784

Cleared

Denied

Siemens Medical Solutions USA, Inc. has 784 FDA 510(k) cleared radiology devices. Based in Hoffman Estates, US.

Latest FDA clearance: Sep 2026. Active since 1980.

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 Rheinland of North America, Inc. and Tuv America, Inc.. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.

Siemens Medical Solutions USA, Inc. is one of 26109 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.