QKB

Radiological Image Processing Software For Radiation Therapy

产品代码

QKB

器械名称

Radiological Image Processing Software For Radiation Therapy

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 892.2050

FDA 专业组

Radiology

上市路径

需提交 510(k) 上市前通告

该代码近三年的 510(k)

49 件

FDA 分类定义

To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical and/or artificial radiological images. In these devices, the algorithm training images typically impact device performance. AI based radiological image processing software is intended to be used in the workflow of radiation therapy. Adaptive AI algorithms are not within the scope of this product code. Primary radiation dose calculation or plan optimization for treatment planning are not within scope of this product code.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。

该代码近三年的 510(k)（23 件）

数据窗口为最近三年。最新一件：2026-08-14。