SEZ

Radiological Software Device To Predict Future Breast Cancer Risk

产品代码: SEZ
器械名称: Radiological Software Device To Predict Future Breast Cancer Risk
管理类别: 第 2 类（Class II）
21 CFR 条款: 21 CFR 892.8500
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): 1 件

FDA 分类定义

A radiological software device to predict future breast cancer risk is a device that analyzes radiological images generated by breast imaging modalities and/or inputs derived from radiological images to provide qualified healthcare professionals with a prediction of the risk of future (incident) breast cancer. This device produces a numeric probability and/or risk category indicative of the patients future breast cancer risk from the time the analyzed images were acquired. This device is not intended to diagnose, detect, or inform the treatment of cancer. The output of this device is not intended to guide interpretation of imaging exams.

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：2025-05-30。

510(k) 号	批准日期	申请人	器械名称
DEN240047	2025-05-30	Clairity, Inc.	Allix5

FDA 官方分类页： SEZ

分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。