QDQ

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

产品代码

QDQ

器械名称

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 892.2090

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)

39 件

FDA 分类定义

A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (e.g., mammography , MR, CT, ultrasound, radiography). The device detects, identifies and characterizes lesions suspicious for cancer based on features or information extracted from the images, and may provide information about the presence, location, and characteristics of the lesion to the user. Primary diagnostic and patient management decisions are made by the clinical user.

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)（22 件）

数据窗口为最近三年。最新一件：2026-08-14。

其中 20 件的 Summary 已存档在本站，点 PDF 直接下载；其余给 FDA 官方链接。