Neusoft Medical Systems Co., Ltd.
东软医疗系统股份有限公司
Neusoft Medical Systems Co., Ltd. was founded in 1998 and is headquartered in Shenyang, Liaoning. It develops medical imaging equipment across CT, MRI, DSA, PET/CT, X-ray, ultrasound and radiotherapy plus an MDaaS service platform, and states it has more than 53,000 installations in over 130 countries. Its CT range spans 16-slice systems up to the 512-slice NeuViz Epoch.
NMPA Class III medical device registration for NeuViz Epoch (registration no. 国械注准20203060462)CE (MDD) via TUV SUD, Notified Body 0123, certificate G1 098883 0002 Rev.02 for NeuViz Prime / 128 / 64 In / 16 Classic / 16 Essence (the Epoch is not listed on this certificate)US FDA 510(k) K171201 (NeuViz Prime, 2017-09-13) and K151383 (NeuViz 128)