SHW

Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis

产品代码

SHW

器械名称

Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 864.3755

FDA 专业组

Pathology

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 pathology software algorithm device analyzing digital images for cancer prognosis is a software intended to analyze scanned whole slide images (WSIs) from breast cancer specimens prepared from formalin fixed paraffin-embedded (FFPE) tissue and stained using Hematoxylin & Eosin (H&E) stains. The device provides prognostic risk estimates which are intended to assist physicians with prognostic risk-based decisions along with other clinicopathological factors. The device is not intended to determine a clinical diagnosis.

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：2026-05-04。