Shimadzu Medical Systems Receives FDA 510(k) for FluoroSpeed X1 RF System

August 9, 2019 — Shimadzu Medical Systems USA, a subsidiary of Shimadzu Corp., announced they have received U.S. Food and Drug Administration (FDA) 510(k) clearance for the FluoroSpeed X1 patient side conventional radiographic fluoroscopy (RF) table system.

The FluoroSpeed X1 is a conventional RF table system offering high image quality and a multitude of features that improve workflow and operator efficiencies, which contributes to lower cost of care.

As the newest U.S.-based product in the FluoroSpeed series, the FluoroSpeed X1 with its 665 lb. static patient weight and 500 lb. all motion weight, easily performs both bariatric and routine daily fluoroscopic and radiographic exams.

Shimadzu said the system supports a wide range of general RF applications, such as chest, abdomen or extremities along with upper GIs, modified swallows and even joint injections. New features that improve room workflow include an ambidextrous control handle for the park-anywhere imaging deck along with fingertip access to anatomical programs (APRs), image recording functions and site-specific programmable function buttons.

The FluoroSpeed X1 conventional RF system, designed with patient-side table controls for the operator, is practically priced and comes equipped with a 17 x17-inch dynamic digital X‐ray detector (FPD) in the table bucky, allowing it to both be used for fluoroscopy as well as radiographic exams. With its 31.5‐inch aperture opening between table top and deck, the X1 is the ideal digital RF system providing access for imaging patients in wheelchairs, yet it can fit in smaller rooms where space is limited. Furthermore, by adding a second X‐ray tube on an overhead rail, the system functionality and versatility of the room increases exponentially.

The FluoroSpeed X1 is now available for sale throughout the U.S.

Interact with a 360 photo of a Shimadzu FluoroSpeed X1 Fluoroscopy imaging system
 

Watch a VIDEO: Demonstration of the Shimadzu FluoroSpeed X1 Radiographic Fluoroscopy System
 

For more information: www.shimadzu.com/med