Device typeRobotic surgical navigation system: An assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise procedural movement and placement (navigation) during the procedure (e.g., placement of a pedicle screw in spinal surgery). It typically consists of an operator's console featuring a robotic surgical arm(s) and a video camera used to track the robotic instrumentation. The input to the computer is usually by means of an existing CT or MRI scan. The system tracks the instrumentation by reading the location points giving a three-dimensional (3-D) picture of the instrument's position/angulation. It can also be used as a training aid.
FDA categoryCatheter Remote Control System, System, Catheter Or Guidewire, Steerable (Magnetic)
Device IDM58800101100010
Catalog number001-011000-1
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information