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近日,从美国食品药品管理局(Food and Drug Administration,简称FDA)传来消息,沈阳东软数字医疗公司研制生产的CT—C3000型螺旋CT顺利通过了美国FDA认证,从而实现了国产大型医学影像设备通过美国FDA认证零的突破,此举充分表明东软数字医疗产品在安全性及有效性方面已达到国际先进水平,同时也预示着以挑剔、严格著称的国际市场已向中国数字医疗产业敞开了大门。FDA认证,是指进入美国市场的所有产品,必须完全符合该产品所涉及的所有FDA管理条例
Recently, it was reported from the Food and Drug Administration (FDA) that the CT-C3000 Spiral CT developed and produced by Shenyang Neusoft Digital Medical Co., Ltd. successfully passed the US FDA certification, thereby realizing a large domestic medical imaging equipment. Through the zero breakthrough of the US FDA certification, this move fully demonstrates that Neusoft digital medical products have reached international advanced level in terms of safety and effectiveness, and also indicates that the international market with critical and strict reputation has opened its doors to the Chinese digital medical industry. . FDA certification means that all products entering the U.S. market must fully comply with all FDA regulations covered by the product.