FDA clears six Siemens AI imaging platforms

Siemens Healthineers said on May 13 that the U.S. Food and Drug Administration had cleared six interventional imaging platforms that use the company’s Optiq AI imaging chain. The cleared systems include four versions of the Artis vision platform and floor configurations of the Artis icono.explore and Artis genio systems, according to Diagnostic Imaging and Siemens materials. The FDA action was described as 510(k) clearance, the pathway the agency uses for many medical devices that are found substantially equivalent to legally marketed products. FDA materials say a 510(k) is a premarket notification submitted before a device is marketed. Optiq AI is the common feature across the six systems. Siemens said the imaging chain uses AI-based, real-time denoising during image formation and applies automatic parameter selection during image acquisition. (diagnosticimaging.com) The company said that process is intended to deliver higher-quality, low-dose images for image-guided procedures. Siemens said the denoising applies to fluoroscopy, acquisition and digital subtraction angiography, and that the software is aimed at interventional radiology, cardiology and minimally invasive surgery. (diagnosticimaging.com) In its November 30, 2025 presentation of Optiq AI at the Radiological Society of North America meeting, the company said the system dynamically adjusts settings including tube voltage, tube current, pulse width and detector dose as the procedure changes. Kris McVey, head of angiography in the advanced therapies business at Siemens Healthineers North America, said in comments published by Diagnostic Imaging that “increased precision is of paramount importance” as more complex procedures move into interventional labs. McVey said the new Artis portfolio was built to deliver the image quality clinicians need while accounting for “the needs and budget of every type of healthcare facility.” (siemens-healthineers.com) Four Artis vision variants make up most of the newly cleared group. Diagnostic Imaging said those versions include floor, biplane, ceiling and pheno, which it described as a floor-mounted robotic configuration. Siemens’ product materials say Artis icono.vision is designed for a broad procedure mix in a single interventional suite and is powered by Optiq AI. (diagnosticimaging.com) March 4, 2026 materials from Siemens tied the same angiography family to interventional radiology work such as embolization treatment of liver cancer. In that presentation, the company said Artis genio, Artis icono.explore and Artis icono.vision also include automated motion correction in cone beam CT datasets and software for planning and device navigation. The next step is commercial use across Siemens’ interventional portfolio. (diagnosticimaging.com) Siemens has already said Optiq AI is available on Artis genio, Artis icono.explore and Artis icono.vision platforms, and the company’s U.S. product pages now describe those systems as part of its current angiography lineup. (siemens-healthineers.com 1) (siemens-healthineers.com 2)