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China's Neusoft gets FDA nod for CT scanner

05 December 2012 | Regulatory | By BioSpectrum Bureau

China's Neusoft gets FDA clearance

Neusoft Medical NeuViz 64 CT scanner gets FDA 510k clearance

Neusoft Medical NeuViz 64 CT scanner gets FDA 510k clearance

Singapore: NeuViz 64 multi-slice CT scanner from China-based Neusoft Medical Systems, a wholly-owned subsidiary of Neusoft has received FDA 510k clearance. The FDA approval of the NeuViz 64 CT further validates Neusoft Medical's capacity to introduce high quality technology that meets the requirements of clinical practice around the world. Neusoft Medical has pioneered the rapid evolution of CT technology to meet the global demand for high-quality, affordable imaging.

NeuViz 64 provides a clinical and financial solution for currently challenged paradigm which places clinical advantages of 64-slice scanning beyond the financial budget of most hospitals and imaging centers.

The NeuViz 64 design delivers low-dose scanning, high patient throughput, ease-of-use, performs advanced cardiac imaging, and provides a wide variety of clinically-relevant post processing and diagnostic techniques. The Quad-Sampling Technology can improve resolution, reduce artifact and extend scanning ranges.

ClearView Reconstruction removes noise while preserving details potentially providing low-dose image quality that is superior to that of full-dose images. A lot of low dose designs have been applied in NeuViz 64 such as 240 degree exposure, pediatric protocols, and ECG dose modulation among others. Powerful workstation (AVW) can offer full range of clinical applications and optimized intuitive workflow guides technologists to use easily and quickly.

Neusoft Medical continues to expand its global presence around the world, and it has achieved ISO9001 quality system certification for all products, among which, CT, MRI, X-ray, diagnostic ultrasound and PET products have been certified by CE and FDA. Beside the released 64 slice CT, Neusoft Medical is innovating 64+ slice CT, and is also focusing on innovation at all times to support lower dose and better image for good diagnosis.

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