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Minimally Invasive Prostate Surgery Navigation System (Model: AmaKris SR1-A-1) is intended for use by the trained physician or urologist to perform the computer-assisted procedures through transperineal skin under realtime transrectal ultrasound guidance. It provides the capability to register and fuse with MRI medical images in DICOM format. It provides real-time 3D visualization for prostate, biopsy needle, and probe. It also provides the ability to display an image coordinates and guidewire that means the projected future path of the biopsy needle. Other software feature include patient data management, prostate and tumor modeling, 3D image registration. Minimally Invasive Prostate Surgery Navigation System (Model: AmaKris SR1-A-1) is intended for treatment planning and guidance for prostate surgical procedures in a clinical setting.

To help physician or urologist to perform needling procedures on prostate, AmaKris SR1-A-1 serves as a needle guide, which enables the needling procedures safer, faster and more precision with lesser side effects such as infection and internal hemorrhage. AmaKris SR1-A-1 is a computer-assisted medical device to assist the surgeon perform targeted transperineal prostate biopsy in conjunction with the guidance of transrectal ultrasound. The device serves as a needle quide only. Different from the conventional hand-held probe quidance and operator-dependent manual biopsy targeting, AmaKris SR1-A-1 is a platform-hosted motorized device integrating a probe-driving system for 3D image collection and a precise biopsy quidance mechanism (biopsy needle platform) to control the orientation of needle insertion and depth of puncture. This system is intended to be used with adult patients. The device has a graphics user interface (GUI) that can provide a complete view of the 3D prostate to the physicians. The system allows users to draw contour curves of the organ/tumor referring to the transversal images, then the software performs contour fitting and generates the 3D model, based on which the prostate volume is calculated, and the systematic biopsy plan is made. This plan can be customized and the approved plan will be used to control the biopsy needle platform to guide the needle positioning for the manual puncture. The device is intended for use by a trained urologist or physician to perform the computerassisted transperineal prostate biopsy under transrectal ultrasound guidance. It shall be used in conjunction with a third-party ultrasound machine and endorectal probe that supports type-B ultrasound, and a third-party prostate biopsy gun and needle. The device services as a biopsy needle guide only. The insertion of biopsy needle will be done by the urologist. AmaKris SR1-A-1 is composed of two modules: Navigation Manipulator and Intelligent Surgical Console.