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Medical Devices / Submissions and Approvals

FDA Clears Siemens Healthineers’ Angiography Platform

Sept. 19, 2019
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The FDA granted Siemens Healthineers 510(k) clearance for its Artis icono, a single suite that combines various angiography systems.

The platform’s main feature is the new Optiq image chain, which processes 2D images to  increases image quality, automatically achieving optimal contrast at safe patient radiation doses.

The platform is a floor-mounted, single-plane system intended for use in surgical, vascular, oncology and interventional cardiology procedures.

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