QYV

Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

产品代码

QYV

器械名称

Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 864.3900

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

The digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm is a prescription in vitro diagnostic device consisting of an automated digital slide creation, viewing, and management system intended to aid in the review of digital images of slides prepared from Pap test specimens and conventional Pap smears by selecting and presenting areas of interest to facilitate interpretation by the reader. The AI software algorithm uses machine learning techniques to provide information to the user about the presence, location, or characteristics of areas of the image with clinical implications. Information from this device is intended to assist the user in rendering a cytology 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：2024-01-31。