QVD

Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

产品代码

QVD

器械名称

Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 892.2055

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)

1 件

FDA 分类定义

A radiological machine learning quantitative imaging software with predetermined change control plan is a software-only device which employs machine learning algorithms on radiological images to provide quantitative imaging outputs. The device includes functions to support outputs such as view selection, segmentation and landmarking. The design specifications include planned modifications that may be made to the device consistent with an established predetermined change control plan.

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）。