Two new 64/128-Slice CT Scanners Cleared by the FDA

A major diagnostic imaging equipment provider has announced US FDA clearance of two new 64/128-slice Computed Tomography (CT) scanners.

The Food and Drug Administration (FDA; Silver Spring, MD, USA) provided clearance for the vendor to market the scanners, which are Smart-Dose (XR-29) compliant, feature lower-dose patient safety capabilities, and workflow and ease-of-use improvements to enable increased daily scanning volumes.


The Scenaria SE 64 and SE 128 scanners were developed by Hitachi Medical Systems America (Twinsburg, OH, USA) within its Scenaria Platform. The company produces a wide range of diagnostic imaging equipment including Magnetic Resonance Imaging (MRI), CT, and ultrasound systems.

The workflow enhancements of the new models include a 40% increase in standard Recon Speed (up to 50 images per second) and Multi-Planar Reformatting (MPR) Recon Speed, and increased automation of common operator functions. In addition, the standard patient table weight capacity was upgraded to nearly 250 kg, to accommodate bariatric patients.

Sheldon Schaffer, VP and general manager MR/CT, Hitachi Medical Systems America, said, “With Scenaria SE, Hitachi is demonstrating again the unmatched value of our customer support by providing a no-charge upgrade to full Scenaria SE capabilities for our entire installed base of Scenaria 128 customers, covered by warranty or full service agreements. This upgrade is in addition to our exceptional commitments of unlimited no-charge Applications Training revisits and full replacement coverage of X-ray tubes without cost proration, under our warranty.”

Related Links:
Hitachi Medical Systems America
US Food and Drug Administration