SGJ

Ultrasound Imaging System For Acquiring Images At Home By Lay Users

产品代码

SGJ

器械名称

Ultrasound Imaging System For Acquiring Images At Home By Lay Users

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 892.1590

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)

1 件

FDA 分类定义

An ultrasound imaging system for acquiring images at home by lay users is a prescription home use device that may consist of hardware and/or software intended for acquiring ultrasound images for interpretation by a qualified health care professional (e.g., fetal images for determination of fetal heart rate). The device provides guidance to lay users to aid image acquisition.

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：2025-10-31。