Shimadzu gets FDA nod for new R/F system

By staff writers

August 12, 2019 -- Shimadzu Medical Systems USA has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for FluoroSpeed X1, a new radiography/fluoroscopy (R/F) system.

FluoroSpeed X1 is a conventional table R/F room that's designed to offer high image quality and a variety of features to improve workflow and operator efficiency. The system can accommodate patients weighing up to 665 lb for static exams and 500 lb for motion studies; it performs both bariatric and routine daily fluoroscopy and radiography exams.

Shimadzu designed FluoroSpeed X1 to provide a balance of functionality for a wide range of general R/F applications, such as chest, abdomen, or extremity studies, along with upper gastrointestinal exams, modified swallows, and even joint injections. The system sports a 17 x 17-inch digital detector in the table bucky.

The system also has a 31.5-inch aperture opening between tabletop and deck to provide easy access for patients in wheelchairs, and it can be sited in small spaces. Users of the system can add a second x-ray tube on an overhead rail, increasing the functionality and versatility of the system.

FluoroSpeed X1 has begun shipping commercially in the U.S., according to Shimadzu.

Copyright © 2019

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