Globus Medical Gets 510(k) Clearance for Interoperative Imaging System

August 19, 2021

Audubon, Pa.-based Globus Medical has received 510(k) marketing clearance from the FDA for its Excelsius3D imaging system.

A mobile X-ray system designed for 2D fluoroscopy, 2D digital radiography and 3D imaging, the Excelsius3D can be used as a standalone unit or as an extension of the company’s other Excelsius devices.

The imaging platform combines cone-beam computed tomography, fluoroscopy, and high-resolution digital radiography, eliminating the need for multiple imaging systems during surgical procedures.

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