SGJ

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Ultrasound Imaging System For Acquiring Images At Home By Lay Users

Device class

Class II (moderate risk)

Regulation

21 CFR 892.1590

Medical specialty

Radiology

FDA definition

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.

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