QHA

X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

产品代码

QHA

器械名称

X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 892.1600

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)

7 件

FDA 分类定义

X-ray angiographic imaging based coronary vascular simulation software device is a prescription device that provides an image analysis tool to assess blood flow in the coronary vascular system using X-ray angiographic imaging data. X-ray angiographic imaging based coronary vascular simulation software device solves algorithms and yields simulation-based metrics for certain cardiology applications. X-ray angiographic imaging based coronary vascular simulation software device cannot be used alone for clinical decision making and clinical management, and is a tool intended to generate results for use and review by a qualified clinician.

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)（3 件）

数据窗口为最近三年。最新一件：2025-10-17。

其中 3 件的 Summary 已存档在本站，点 PDF 直接下载；其余给 FDA 官方链接。