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Medical Devices / Submissions and Approvals

FDA Grants 510(k) Approval for Siemens’ Mobile C-Arm

Nov. 8, 2018

The FDA has cleared Siemens Healthineers’ Cios Spin, a mobile C-arm that produces 3D images for improved quality assurance during surgical procedures.

The device is used to provide 3D imaging similar to computed tomography (CT) for orthopedic, spinal and traumatic surgery.

The 3D images the Cios Spin produces can remove the need for CT after the procedure and can help reduce the number of needed revisions.

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