QWO

Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.

产品代码: QWO
器械名称: Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.
管理类别: 第 2 类（Class II）
21 CFR 条款: 21 CFR 892.2085
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): 4 件

FDA 分类定义

Radiology software for referral of findings related to fibrotic lung disease is a prescription image processing device that analyzes computed tomography images to suggest the presence of disease or of an imaging finding suggestive of disease. The output of this device is intended to be used as adjunctive information as part of a referral pathway in the overall diagnostic assessment process.

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)（4 件）

数据窗口为最近三年。最新一件：2025-11-07。

510(k) 号	批准日期	申请人	器械名称
K252041	2025-11-07	Imvaria, Inc.	Fibresolve (with PCCP) 摘要
K241891	2025-01-10	Imvaria, Inc.	ScreenDx 摘要
K242467	2024-12-19	Imbio, Inc.	IQ-UIP 摘要
DEN220040	2024-01-12	Imvaria, Inc.	Fibresolve

FDA 官方分类页： QWO

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。