QXZ

Adjunctive Epicardial Vascular Physiologic Status Indicator

产品代码

QXZ

器械名称

Adjunctive Epicardial Vascular Physiologic Status Indicator

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 870.2200

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)

1 件

FDA 分类定义

The adjunctive epicardial vascular physiologic status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting the possible presence of functionally significant coronary artery disease to suggest the need for further testing. This device is intended for adjunctive use with other clinical workup or patient information and is not intended to quantify the degree to which epicardial disease is limiting flow through a vessel nor is it intended to independently direct therapy.

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）。