Home » CurveBeam Wins 510(k) Clearance for Weight Bearing CT System
CurveBeam Wins 510(k) Clearance for Weight Bearing CT System
Devices Submissions and Approvals
CurveBeam received FDA 510(k) marketing clearance for its LineUP multi-extremity weight bearing CT system.
The system allows radiologists and orthopedic specialists to visualize three-dimensional bone detail of the lower extremities while the patient is standing so they can assess the anatomy in the weight-bearing position.
The LineUP can perform bilateral scans of legs from below the heel to above the knee and accessories enable scanning of hands, wrists and elbows. The system has minimal shielding requirements and the radiation dose to the patient is significantly lower than that of a conventional CT scan.
The LineUP recently earned a CE Mark in Europe.