Siemens AG - FDA 510(k) Cleared Devices

Siemens AG, is a global technology company with a manufacturing facility in Iselin, US. The company develops advanced imaging and diagnostic solutions, primarily for Radiology applications.

Siemens AG has received #15# FDA 510(k) clearances from #15# total submissions, with no denied submissions on record. The company's regulatory activity spans from 1995 to 2015, with Radiology devices representing the dominant focus of its FDA-cleared portfolio. This includes advanced imaging software platforms and hardware systems for cardiac, oncology, neuro, and body imaging applications.

The company's cleared devices include the syngo®.via software platform, CT imaging packages for specialized clinical applications, and advanced display and imaging hardware. These products reflect Siemens' expertise in cross-sectional imaging and clinical decision support tools.

This regulatory record is historical; no FDA 510(k) clearances have been submitted in more than five years. Explore the complete list of device names, product codes, and clearance dates in the database.

Regulatory submissions have been managed by Tuv Sud America, Inc. and Tuv America, Inc..