Medical Device Manufacturer · US , Hoffman Estates , IL

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

782 submissions · 782 cleared · Since 1980

Recent clearances: syngo.CT Coronary Cockpit, MAMMOMAT B.brilliant (11372950), ACUSON Sequoia Diagnostic Ultrasound System

782
Total
782
Cleared
0
Denied

Siemens Medical Solutions USA, Inc. has 782 FDA 510(k) cleared radiology devices. Based in Hoffman Estates, US.

Latest FDA clearance: Jun 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.

FDA 510(k) Regulatory Record - Siemens Medical Solutions USA, Inc.

782 devices
1-12 of 782

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