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ProBx Software is intended for use as follows: · ProBx Software is a computer-based image-guidance accessory intended for use in conjunction with commercially available Magnetic Resonance Imaging (MRI) systems and interventional devices. · ProBx Software helps physicians guide biopsy instrumentation to targets that have been defined by the physician in MRI. The Software provides the clinician with image analysis and display of pre-procedural MRI images of tracked accessory hardware and the target organs, along with the projected path to the Software displays an MRI image of the current location of the interventional instrument for positioning confirmation. · ProBx Software is intended to be used by physicians in a clinical setting for treatment planning and guidance for clinical, interventional, and/or diagnostic procedures of the prostate.

ProBx Software along with ProBx Hardware accessories is used for in-bore Magnetic Resonance Imaging (MRI) guided interventional and diagnostic procedures of the prostate. The ProBx Software is intended to be loaded onto a commercially available workstation and used as an accessory to commercially available MRI systems. The software receives pre-procedural and intra-procedural DICOM images and provides 2D and 3D visualization for treatment planning. The Software performs calculations on user-selected target locations to assist the clinician in manually utilizing the tracked accessory hardware to reach targets. The Software also provides MRI scan confirmation of positioning during the procedure.