Plexus has received approval from the Food and Drug Administration (FDA) to manufacture finished class II medical devices at its Kelso manufacturing site in Scotland.
Plexus achieved the accreditation following a thorough assessment of its work with SuperSonic Imagine, a French medical OEM, to design and manufacture its Aixplorer ultrasound system.
Plexus has worked closely with SuperSonic Imagine through the product realisation process, providing support with prototyping, live scan testing, electronic and high level systems assembly as well as providing direct order fulfilment. Plexus, which also holds ISO13845 accreditation in recognition of the quality management systems in place at its Kelso manufacturing facility, has the capabilities to configure Aixplorer to the specific requirements of SuperSonic Imagine customers prior to shipping.
Aixplorer is based on a flexible software structure which allows an image acquisition rate of 200,000 images per second, using MultiWave Technology, ensuring impeccable image quality and providing revolutionary ShearWave Elastography. ShearWave Elastography displays, in real time, true local tissue elasticity in a colour-coded map to better characterise and assess tissue stiffness.
Recently the Aixplorer extended the limits of ultrasound technology by introducing UltraFast Doppler, uniting colour flow imaging with pulsed wave Doppler for comprehensive flow information without compromises and complete spectral Doppler analysis in seconds. The Aixplorer is a complete ultrasound system with FDA approval and CE Mark since 2009, and with several applications: breast, liver, abdomen, thyroid, musculoskeletal, prostate, gynaecology, 3D breast and vascular.
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