Tag: FDA

FDA OKs Siemens Healthineers’ Mammomat B.brilliant Platform

Siemens Healthineers has obtained FDA 510(k) clearance for the Mammomat B.brilliant mammography platform, featuring enhancements in user ergonomics and workflow, as well as reduced patient discomfort. Additionally, they have submitted a Premarket Approval application for the 3D tomosynthesis portion of the system.

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Siemens Healthineers Magnetom Terra.X Gets FDA Nod

Siemens Healthineers has nabbed U.S. FDA clearance for the Magnetom Terra.X, a second-generation 7-tesla MRI scanner with Ultra IQ Technology and improved hardware, including XA60A software, enhancing image quality, enabling advanced clinical imaging and research capabilities.