QXO

Cardiovascular Machine Learning-Based Notification Software

产品代码

QXO

器械名称

Cardiovascular Machine Learning-Based Notification Software

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 870.2380

FDA 专业组

Cardiovascular

上市路径

需提交 510(k) 上市前通告

该代码近三年的 510(k)

2 件

FDA 分类定义

Cardiovascular machine learning-based notification software employs machine learning techniques to suggest the likelihood of a cardiovascular disease or condition for further referral or diagnostic follow-up. The software identifies a single condition based on one or more non-invasive physiological inputs as part of routine medical care. It is intended as the basis for further testing and is not intended to provide diagnostic quality output. It is not intended to identify or detect arrhythmias.

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)（1 件）

数据窗口为最近三年。最新一件：2026-06-08。

其中 1 件的 Summary 已存档在本站，点 PDF 直接下载；其余给 FDA 官方链接。