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Medical Devices / Submissions and Approvals

Shimadzu’s Earns 510(k) Clearance for Radiographic Table

Aug. 13, 2019
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The FDA has granted Shimadzu Medical Systems 510(k) clearance for its Fluorospeed X1 platform, a radiographic/fluoroscopic (RF) system.

The Torrance, California devicemaker’s system offers high image quality and multiple features to improve workflow, including image recording and programmable function buttons.

The system supports a wide range of general RF applications, such as chest, abdomen, or extremities along with Upper GI's.

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