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The Vu-Path Ultrasound System with associated probe and accessories provide ultrasound guidance for the placement of needles and catheters in vascular structures adults aged 22 and older. Ultrasound imaging of vascular structures and surrounding tissue may also be performed. The ultrasound probe is only intended to be placed on the skin and should not be advanced percutaneously. The device provides B-Mode and Color Doppler modes of operation. The Vu-Path Ultrasound system needle guidance technology is indicated for use by appropriately-trained healtheare professionals to provide them with visual tools for passive tracking of a needle with respect to ultrasound image data.

The Vu-Path Ultrasound System employs the same core scientific technology as the other ultrasound devices: digital acquisition, processing, analysis and display capability. Piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and shown on the device display. The Vu-Path is designed primarily to assist physicians in gaining vascular access to major veins and arteries. The system consists of a beamformer and a transducer that operates in two modes, B-Mode and Color Doppler. A single USB connection transfers the information between the beamformer and a user provided computer with display. The application software is installed on the user provided computer. The Vu-Path needle guide attaches over the sheathed transducer and has an integral needle channel that provides a path for a needle to be introduced into the target location.