Core Viewpoint - Shanghai United Imaging Healthcare Co., Ltd. has received a medical device registration certificate for its photon-counting spectral CT, marking a significant breakthrough in China's medical technology sector and making it the first Chinese company to commercialize this technology globally [1][2]. Group 1: Product Development and Innovation - The photon-counting spectral CT, named uCT Ultima, is the first of its kind developed in China, representing a major advancement in the "14th Five-Year Plan" national key research and development project [1][2]. - The company has collaborated with several institutions, including Fudan University Zhongshan Hospital and Shanghai Jiao Tong University School of Medicine, to leverage their strengths in machine development, clinical application, and testing for the photon-counting spectral CT [2]. Group 2: Market Presence and Regulatory Approvals - The company has registered its products in over 80 countries and regions globally, with more than 140 products approved for market, including 53 that received FDA 510(k) certification and 57 that obtained EU CE marking [3]. - Recent flagship products include the uMR Ultra MRI system, the uCT SiriuX dual-source CT system, and the uAngio AVIVA zero-noise DSA system, which have set new standards in their respective categories [3]. Group 3: Strategic Impact - The acquisition of the medical device registration certificate will enhance the company's product variety, catering to diverse clinical needs and strengthening its core competitiveness [4].