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GE Healthcare Earns FDA Clearance for Surgical Imaging System

March 25, 2021

GE Healthcare’s OEC 3D, a surgical system for 3D and 2D imaging, has earned 510(k) clearance from the FDA.

The system features a 3D C-arm that provides x-ray imaging during surgical procedures for complex spine and joint replacement. It also includes a separate C-arm for 2D imaging.

The device can quickly present 3D images on a viewer as well as advanced analyses for surgical assessments. It can also link up with other intraoperative technologies. such as navigation and robotics systems.

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