Samsung Electronics (LON:BC94) subsidiary Samsung NeuroLogica said today it won FDA 510(k) clearance for its RS85A ultrasound device.
The RS85A system features new Samsung technology including the MV-Flow feature which allows for the visualization of slow-flow micro vascularized structures and S-Shearwave Imaging technology which quantifies the elasticity of tissue or lesions.
The newly cleared system also features the company’s CEUS+ technology for diagnosing and characterizing liver lesions and the S-Fusion system which allows simultaneous localization of lesions using real-time ultrasound alongside volumetric imaging modalities.
“We are pleased to launch the RS85A, a new premium general imaging ultrasound system with superior image quality and usability based on Samsung’s advanced ultrasound and radiology technologies. The RS85A embodies Samsung’s commitment to providing leading technologies to healthcare providers by combining our key values of access, accuracy and efficiency,” Samsung NeuroLogica prez & CEO Philip Sullivan said in a prepared statement.
Samsung NeuroLogica said the RS85A ultrasound’s design was intended to help decrease user fatigue and repetitive motions and features an enhanced monitor arm and increased range of motion and tilt.
“Samsung has built innovative and cutting-edge diagnostic ultrasound products for more than 30 years. We are so confident that our RS85A ultrasound system will perform reliably and be the system that you can depend on for years to come, that we are proud to offer a 5-year warranty standard, at no additional cost,” Samsung NeuroLogica sales VP David Legg said in a press release.
