FDA Clears Toshiba CT System

Tustin, Calif.-based Toshiba America Medical Systems Inc. has received 510(k) clearance from the U.S Food and Drug Administration (FDA) for its Aquilion Prime 80 series CT (computerized tomography) system. According to the company, Aquilion Prime produces high-quality clinical images, and is designed to reduce radiation exposure with Adaptive Iterative Dose Reduction 3D (AIDR 3D). The system can generate 80 unique “slices” per rotation, but can also be upgraded to generate 160 slices.

Tim Nicholson, senior manager of market development, CT Business Unit, Toshiba, said the Aquilion system would give “hospitals the opportunity to conduct advanced exams in mere seconds and grow clinical abilities based on patient needs results in improved patient care and overall departmental efficiency.”

The Aquilion Prime features a 0.5 mm detector, a 7.5 MHU large-capacity tube and 0.35 second scanning. This high-speed rotation allows rapid data acquisition and shortens scan times while the fast reconstruction unit further improves throughput, all of which help provide faster, safer and more accurate diagnoses. The system also features a 78 cm aperture gantry, the largest currently available in a high-end CT system. The combination of a 660-pound patient-weight-capacity couch with a large gantry bore optimizes the system for routine clinical scanning or bariatric patient studies.

To reinforce the principle of As Low As Reasonably Achievable (ALARA) imaging, AIDR 3D and NEMA XR 25 Dose Check Software are standard features on the Aquilion Prime 80 series. AIDR 3D, the newest dose-reduction technology for the Aquilion CT product line, is an iterative process that helps to remove noise from the image with reduced radiation dose. Among other features the company touted, Toshiba’s NEMA XR 25 Dose Check Software is designed to enhance user awareness of the radiation dose being administered to patients. The software includes Dose Alert and Dose Notification, addressing the two main components of the Medical Technology and Imaging Alliance’s (MITA’s) CT Dose Check Initiative, as well as Tracking and Digital Imaging and Communications in Medicine (DICOM), to further enhance dose awareness. DICOM was founded by MITA to create a standard for how imaging information is communicated and disseminated.

Toshiba Medical Systems Corporation is a global provider of medical diagnostic imaging systems and comprehensive medical solutions, such as CT, X-ray and vascular, ultrasound, nuclear medicine and MRI systems, as well as information systems for medical institutions. Toshiba Medical Systems Corporation is a wholly owned subsidiary of Toshiba.