Toshiba Gets FDA Clearance for Higher Powered CT System

Tustin, Calif.-based Toshiba America Medical Systems Inc. has earned 510(k) clearance from the U.S. Food and Drug Administration for its Aquilion Lightning with a more powerful 50-kW generator. According to the company, the Aquilion Lightning meets the business and clinical needs of hospitals looking for a reliable, premium-component, entry-level CT (computed tomography) system that maximizes their equipment investment.

The Aquilion Lightning is a 16-detector row system designed for routine volumetric scanning. It has a small footprint to allow providers to save on both space and cost, without sacrificing exceptional technology. The system offers the same Purevision CT Detector technology that is used in premium Toshiba CT systems and includes AIDR 3D Enhanced to help reduce dose and improve patient safety. To simplify complex scans for more consistent imaging, the system comes standard with Adaptive Diagnostic solutions, such as Single Energy Metal Artifact Reduction (SEMART) and Suresubtraction. These technologies, along with the industry’s thinnest slices, at 0.5 mm, and a 78 cm bore that is the widest in the 16-row detector radiology segment, help optimize workflow and patient comfort.

“Toshiba CT puts customers first by providing top-tier solutions on every scanner, including our entry-level systems with a low cost of ownership,” said Dominic Smith, senior director, CT, PET/CT, and MR Business Units, Toshiba. “With numerous features found in our high-end Aquilion scanners, the Aquilion Lightning ensures our customers don’t need to compromise quality to meet their business goals.”

Toshiba America Medical Systems makes and services radiology and cardiovascular systems, including CT, MR, ultrasound, X-ray and cardiovascular equipment, and coordinates clinical diagnostic imaging research for all modalities in the United States.