医用诊断X射线机

京械注准20192060293

北京万东医疗科技股份有限公司

北京市朝阳区酒仙桥东路9号院3号楼

北京市朝阳区酒仙桥东路9号院3号楼

医用诊断X射线机

第二类

<p> <span style="font-size: 16px"><span style="font-family: simsun">DRF-5A、DRF-5B、DRF-5C、DRF-5D型</span></span></p>

<p> <span style="font-size: 16px"><span style="font-family: simsun">产品由高频高压发生装置GFS802-3、X射线管组件（E7254X、RAY-14_1、E7869X、RAD-92）、限束器XS5-2、诊断床ZC45SY-4、平板探测器（WDF 4343RF、PaxScan4343DXV）、数字图像系统（TX-DSI3000A、TX-DSI3000B）、显示器和工作站主机组成。 </span></span></p><table align="center" border="1" cellpadding="0" cellspacing="0" style="width: 463px" width="463"> <tbody> <tr> <td colspan="2" rowspan="2" style="width: 121px; height: 21px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">名称</span></span></p> </td> <td rowspan="2" style="width: 116px; height: 21px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">型号</span></span></p> </td> <td colspan="4" style="width: 226px; height: 21px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">数量</span></span></p> </td> </tr> <tr> <td style="width: 56px; height: 18px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">DRF-5A</span></span></p> </td> <td style="width: 56px; height: 18px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">DRF-5B</span></span></p> </td> <td style="width: 56px; height: 18px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">DRF-5C</span></span></p> </td> <td style="width: 56px; height: 18px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">DRF-5D</span></span></p> </td> </tr> <tr> <td rowspan="6" style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">X射线<br /> 发生<br /> 装置</span></span></p> </td> <td style="width: 66px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">高频高压<br /> 发生装置</span></span></p> </td> <td style="width: 116px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">GFS802-3</span></span></p> </td> <td colspan="4" style="width: 226px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">1</span></span></p> </td> </tr> <tr> <td rowspan="4" style="width: 66px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">X射线管<br /> 组件</span></span></p> </td> <td style="width: 116px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">E7254X</span></span></p> </td> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">1</span></span></p> </td> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">-</span></span></p> </td> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">-</span></span></p> </td> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">-</span></span></p> </td> </tr> <tr> <td style="width: 116px; height: 5px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">RAY-14_1</span></span></p> </td> <td style="width: 56px; height: 5px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">-</span></span></p> </td> <td style="width: 56px; height: 5px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">1</span></span></p> </td> <td style="width: 56px; height: 5px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">-</span></span></p> </td> <td style="width: 56px; height: 5px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">-</span></span></p> </td> </tr> <tr> <td style="width: 116px; height: 19px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">E7869X</span></span></p> </td> <td style="width: 56px; height: 19px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">-</span></span></p> </td> <td style="width: 56px; height: 19px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">-</span></span></p> </td> <td style="width: 56px; height: 19px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">1</span></span></p> </td> <td style="width: 56px; height: 19px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">-</span></span></p> </td> </tr> <tr> <td style="width: 116px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">RAD-92</span></span></p> </td> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">-</span></span></p> </td> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">-</span></span></p> </td> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">-</span></span></p> </td> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">1</span></span></p> </td> </tr> <tr> <td style="width: 66px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">限束器</span></span></p> </td> <td style="width: 116px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">XS5-2</span></span></p> </td> <td colspan="4" style="width: 226px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">1</span></span></p> </td> </tr> <tr> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">附属<br /> 设备</span></span></p> </td> <td style="width: 66px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">诊断床</span></span></p> </td> <td style="width: 116px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">ZC45SY-4</span></span></p> </td> <td colspan="4" style="width: 226px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">1</span></span></p> </td> </tr> <tr> <td rowspan="6" style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">成像<br /> 系统</span></span></p> </td> <td rowspan="2" style="width: 66px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">平板探测<br /> 器</span></span></p> </td> <td style="width: 116px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">WDF4343RF</span></span></p> </td> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">1</span></span></p> </td> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">1</span></span></p> </td> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">1</span></span></p> </td> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">-</span></span></p> </td> </tr> <tr> <td style="width: 116px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">PaxScan4343DXV</span></span></p> </td> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">-</span></span></p> </td> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">-</span></span></p> </td> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">-</span></span></p> </td> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">1</span></span></p> </td> </tr> <tr> <td rowspan="2" style="width: 66px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">数字图像<br /> 系统</span></span></p> </td> <td style="width: 116px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">TX-DSI3000A</span></span></p> </td> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">1</span></span></p> </td> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">1</span></span></p> </td> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">1</span></span></p> </td> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">-</span></span></p> </td> </tr> <tr> <td style="width: 116px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">TX-DSI3000B</span></span></p> </td> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">-</span></span></p> </td> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">-</span></span></p> </td> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">-</span></span></p> </td> <td style="width: 56px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">1</span></span></p> </td> </tr> <tr> <td style="width: 66px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">显示器</span></span></p> </td> <td style="width: 116px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">-</span></span></p> </td> <td colspan="4" style="width: 226px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">1</span></span></p> </td> </tr> <tr> <td style="width: 66px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">工作站主<br /> 机</span></span></p> </td> <td style="width: 116px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">-</span></span></p> </td> <td colspan="4" style="width: 226px"> <p align="center"> <span style="font-size: 16px"><span style="font-family: simsun">1</span></span></p> </td> </tr> </tbody></table><br>

<p> <span style="font-size: 16px"><span style="font-family: simsun">本产品可供医疗单位做X射线摄影、透视、胃肠检查诊断使用。不适用于心血管造影、乳腺、牙科X射线摄影诊断。</span></span></p>

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产品技术要求

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北京市食品药品监督管理局

2019-06-06

2024-06-05

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