QZS

Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

产品代码

QZS

器械名称

Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 878.1830

FDA 专业组

General, Plastic Surgery

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

其中 Summary 已存档

0 份，可直接下载

FDA 历史累计 510(k)

1 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

A software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer is a prescription device that uses a software algorithm to analyze optical or other physical properties of a skin lesion and returns a classification of the skin lesion. The device is intended for use by a physician not trained in the clinical diagnosis and management of skin cancer as an adjunctive second-read device following identification of a suspicious skin lesion. It is not for use as a standalone diagnostic and is not for use to confirm 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：2024-01-12。