| 放射治疗用锥形束CT图像引导设备技术审评要求探讨 |
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| 引用本文： | 谷晓芳. 放射治疗用锥形束CT图像引导设备技术审评要求探讨[J]. 中国医学物理学杂志, 2018, 0(9): 993-996. DOI: DOI:10.3969/j.issn.1005-202X.2018.09.001 |
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| 作者姓名： | 谷晓芳 |
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| 作者单位： | 国家食品药品监督管理总局医疗器械技术审评中心，北京100081 |
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| 摘 要： | 主要分析放射治疗kV级锥形束CT（CBCT）图像引导系统和诊断用扇形束CT的技术原理及临床应用的差异，包括数据获取方式、图像处理方式、空间分辨率、成像剂量、图像噪声、密度分辨率等方面的差异，从而进一步分析CBCT和扇形束CT技术审评要求中电气安全、性能指标等要求的差异，以及CBCT说明书、注册单元划分的要求，预期为制造商准备CBCT图像引导系统的注册申报资料提供参考。
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| 关 键 词： | 锥形束CT 扇形束CT 图像引导系统 技术审评 电气安全 性能指标 |
Requirements for technical review of CBCT image-guided radiotherapy system |
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| GU Xiaofang. Requirements for technical review of CBCT image-guided radiotherapy system[J]. Chinese Journal of Medical Physics, 2018, 0(9): 993-996. DOI: DOI:10.3969/j.issn.1005-202X.2018.09.001 |
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| Authors: | GU Xiaofang |
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| Affiliation: | Center for Medical Device Evaluation, China Food and Drug Administration, Beijing 100081, China |
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| Abstract: | The differences in technical principles and clinical applications between kV-cone beam computed tomography (CBCT)image-guided radiotherapy system and fan beam CT for diagnosis were analyzed, including differences in data acquisition, imageprocessing, spatial resolution, imaging dose, image noise, density resolution and so on. The differences in the requirements forelectrical safety and performance indexes in the technical review of CBCT and fan beam CT were further analyzed. Then therequirements for CBCT user manual and registration unit division were also discussed. This analysis aims to provide somereferences for manufacturers to apply for the registration of CBCT image-guided radiotherapy system. |
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| Keywords: | cone beam computed tomography fan beam computed tomography image-guided system technical review electricalsafety performance indexes |
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