数字化摄影X射线机-京械注准20222060272-器械数据

产品名称：

数字化摄影X射线机

注册人名称：

北京万东医疗科技股份有限公司

注册(备案)号：

京械注准20222060272

注册人住所：

北京市朝阳区酒仙桥东路9号院3号楼

批准(备案)日期：

2022-07-14

有效期至：

2027-07-13

结构及组成：

由高频高压发生装置、X射线管组件、限束器、DR摄影装置、摄影床、平板探测器、图像采集系统（含工作站主机和显示器）组成。电离室为选配。tttttttttttttt名称ttttttttttttttt型号ttttttttttttttt新东方ttttt1000U1型ttttttttttttttt新东方ttttt1000U2型ttttttttttttttt新东方ttttt1000U3型ttttttttttttttt备注tttttttttttttttttttX射线ttttt发生ttttt装置ttttttttttttttt高频高ttttt压发生ttttt装置tttttttttttttttGFS501-1ttttttttttttttt1ttttttttttttttt1ttttttttttttttt1ttttttttttttttt-tttttttttttttttttttX射线ttttt管组件tttttttttttttttWD-TB56ttttttttttttttt1ttttttttttttttt1ttttttttttttttt-ttttttttttttttt-tttttttttttttttttttX射线ttttt管组件tttttttttttttttWD-TB65ttttttttttttttt-ttttttttttttttt-ttttttttttttttt1ttttttttttttttt-ttttttttttttttttttt限束器tttttttttttttttXS1-4ttttttttttttttt1ttttttttttttttt1ttttttttttttttt1ttttttttttttttt-ttttttttttttttttttt附属ttttt设备tttttttttttttttDR摄影ttttt装置tttttttttttttttSZ-9ttttttttttttttt1ttttttttttttttt1ttttttttttttttt1ttttttttttttttt-ttttttttttttttttttt摄影床tttttttttttttttSC1-2ttttttttttttttt1ttttttttttttttt1ttttttttttttttt1ttttttttttttttt-ttttttttttttttttttt成像ttttt系统ttttttttttttttt平板探ttttt测器tttttttttttttttWDF 4343RWittttttttttttttt1ttttttttttttttt-ttttttttttttttt-ttttttttttttttt-ttttttttttttttttttt平板探ttttt测器tttttttttttttttWDF 4343Rsttttttttttttttt-ttttttttttttttt1ttttttttttttttt1 ttttttttttttttt-ttttttttttttttttttt图像采ttttt集系统tttttttttttttttWD-ACQUIREttttttttttttttt1ttttttttttttttt1ttttttttttttttt1ttttttttttttttt含工作站主机和显示器ttttttttttttttttttt电离室tttttttttttttttNorma 301ittttttttttttttt1ttttttttttttttt1ttttttttttttttt1ttttttttttttttt选配tttttttttttttt附件ttttttt无线遥控器ttttttt--ttttttt1ttttttt1ttttttt1ttttttt选配ttttttttttt语音对讲系统ttttttt--ttttttt1ttttttt1ttttttt1ttttttt选配ttttttttttt急停保护开关ttttttt--ttttttt1ttttttt1ttttttt1ttttttt ttt tt注1：产品使用的显示器和工作站主机可以用具有CCC证书或符合信息安全标准，满足最低性能要求的同类型的产品替换。tt显示器最低性能要求：19英寸，类型：浏览型、液晶，分辨率1280(H)×1024(V)，亮度最大值：不小于300cd/m2。tt工作站主机最低性能要求：CPU:3.6GHz，内存：8G，硬盘：1000G。

适用范围：

本产品可供医疗单位做X射线摄影诊断用。本产品不适用于心血管造影的X射线摄影诊断，亦不适用于乳腺及牙科X射线摄影诊断。

代理公司：

代理公司地址：

变更情况：

生产地址：

北京市朝阳区酒仙桥东路9号院3号楼

型号规格：

新东方1000U1型、新东方1000U2型、新东方1000U3型

产品储存条件及有效期：

10年

管理类别：

第二类

备注：