Siemens Healthineers’ Cios Spin Mobile 3D C-Arm for orthopedic, trauma and spine surgery has been cleared by the FDA for sale in the U.S.
The Cios, according to FDA documents, is a mobile X-ray system designed, “to provide X-ray imaging of the anatomical structures of patients during clinical application. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.”
System Components
“The system has two major components:
- C-arm with X-ray source on one side and a flat panel detector on the opposite side. The C-arm can be angulated in both planes and be lifted vertically, shifted to the side and move forward/backward by an operator.
- The second unit is the image display station with a movable trolley for the image processing and storage system, image display and documentation. Both units are connected to each other with a cable. “
The biggest difference to its predicate device, the Siemens Cios Alpha, according to the FDA documents, is that “…the Flat Panel detector…has been replaced by a CMOS Flat Panel detector”.
In addition, an anti-microbial coating has been added to the trolley and C-Arm, along with the incorporation of several safety features, including visual and audible warnings.
Robert Dewey, vice president of surgical solutions at Malvern, Pennsylvania-based Siemens Healthineers North America, said the system will help the company’s customers, “improve the quality of patient care using precision medicine as well as reduce the additional costs imposed by revision surgery.”
The company submitted the clearance notification back in mid-June 2018. The agency granted clearance on October 30, 2018.
