FDA Announces 510(k) Clearance for LineUP Weight Bearing Multi-Extremity CT System

CurveBeam announced it received US Food and Drug Administration (FDA) 510(k) clearance for its LineUP multi-extremity weight bearing CT system.

The compact system allows radiologists and orthopedic specialists to visualize 3-dimensional bone detail of the lower extremities while the patient stands so the anatomy can be assessed while in the weight bearing or load bearing position.

The LineUP can both bilateral scans of the entire legs from below the heel to above the knee and accessories permit scanning of the hand, wrist and elbow.

“CurveBeam continues to elevate the standard of care for orthopedic extremity imaging, and introduction of the LineUP device is another solid step upwards,” Arun Singh, chief executive officer, president, CurveBeam, said in a statement. “The LineUP is best-in-class for field of view dimensions and image quality. Coupled with CurveBeam’s exemplary customer support and service, the LineUP is posited to revolutionize orthopedic care.”

The system can be plugged into a standard wall outlet and has minimal shielding requirements. Additionally, the radiation dose to the patient is significantly less than a conventional CT scan.

CurveBeam’s InReach system for hand, wrist and elbow received FDA clearance in 2017 and introduced the pedCAT system, permitting bilateral weight bearing scans of the feet and ankles in 2012.

Last month, CurveBeam won the CE Mark approval in the European Union for its LineUP and InReach orthopedic extremity CT scanning systems.