NeuroLogica Receives CE Mark for Elite Mobile Scanners
Samsung Electronics subsidiary NeuroLogica, based in Danvers, Mass., has received the CE mark for its Elite mobile computed tomography (CT) systems, including its OmniTom Elite, BodyTom Elite and CereTom Elite mobile scanners.
The difference between the various systems is the slice number, referring to the number of rows of detectors. The company offers eight-slice, 16-slice and 32-slice CT scanner systems.
The systems aim to transform fixed imaging technologies into point-of-care platforms, the company said.
The new certification is for compliance with the EU Medical Device Regulation, which requires additional technical documentation, clinical data and postmarket surveillance.