www.fdanews.com/articles/204406-siemens-healthineers-gets-fdas-510k-clearance-for-ct-scanner
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Siemens Healthineers Gets FDA’s 510(k) Clearance for CT Scanner
September 15, 2021
Siemens Healthineers has received the FDA’s 510(k) clearance for its single-source computed tomography (CT) scanner, the Somatom X.ceed.
The CT scanner combines high speed and high resolution to simplify CT-guided procedures, according to the Malvern, Pa.-based subsidiary of the German corporation Siemens.
The high-speed scanner can be used in a variety of diagnostic procedures, including cardiac and trauma imaging, as it reduces “motion artifacts when scanning moving structures, such as the heart,” the company says.