The client needed an image-guided surgery system that incorporated optical tracking devices and localization probes to assist surgeons in obtaining precise images of the operative field, particularly an organ.
The Complexity
Complex, multi-component electromechanical system that includes an infrared diode-equipped wand connected to a PC, infrared tracking for the wand, signal processing.
User interface capabilities on the PC,including live image display.
Optical calibration systems and verification procedures of a laser rangefinder for organ surface mapping, and pre-operative software written in IDL to convert CT/MRI slices into 3D images.
Support for 510K submission, including comprehensive documentation and validation to meet regulatory standards.
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