QAS

Radiological Computer-Assisted Triage And Notification Software

产品代码

QAS

器械名称

Radiological Computer-Assisted Triage And Notification Software

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 892.2080

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)

87 件

FDA 分类定义

Radiological computer-assisted triage and notification software is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification .

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)（43 件）

数据窗口为最近三年。最新一件：2026-07-13。

其中 36 件的 Summary 已存档在本站，点 PDF 直接下载；其余给 FDA 官方链接。