CurveBeam Receives FDA Clearance for LineUP Extremity CT System

By Julie A. Vetalice

CurveBeam gained FDA 510(k) clearance for its LineUP multi-extremity CT system. LineUP supports bilateral scans from below the heel to above the knee with the patient in weight bearing position. Additional accessories permit scanning of the hand, wrist and elbow.

The compact system minimizes shielding requirements and patient exposure to radiation.

In April, CurveBeam received CE Mark approval for LineUP and InReach, a cone beam imaging system designed for the hand, wrist/elbow and lower extremities in non-weight bearing positions. InReach received 510(k) clearance in 2017.

CurveBeam’s first extremities CT system, pedCAT, received FDA clearance in 2012 for bilateral weight bearing scans of the foot and ankle.

Sources: CurveBeam; ORTHOWORLD Inc.

Product Labels: Upper Extremity, Lower Extremity

Tags: 510(k) Clearance, Regulatory