QBS

Radiological Computer Assisted Detection/Diagnosis Software For Fracture

产品代码: QBS
器械名称: Radiological Computer Assisted Detection/Diagnosis Software For Fracture
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): 11 件

FDA 分类定义

A radiological computer assisted detection and diagnostic software for suspected fracture is an image processing device intended to aid in the detection, localization, and/or characterization of fracture on acquired medical images (e.g. radiography, MR, CT). The device detects, identifies and/or characterizes fracture based on features or information extracted from images, and may provide information about the presence, location, and/or characteristics of the fracture 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)（5 件）

数据窗口为最近三年。最新一件：2026-08-28。

510(k) 号	批准日期	申请人	器械名称
K261378	2026-08-28	AZmed	Rayvolve AZchest 摘要
K260378	2026-05-12	AZmed	Rayvolve 摘要
K242171	2025-01-17	Milvue	TechCare Trauma 摘要
K240712	2024-11-07	Icometrix NV	icobrain aria 摘要
K240845	2024-07-17	Azmed Sas	Rayvolve 摘要

FDA 官方分类页： QBS

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。