SGJ

Ultrasound Imaging System For Acquiring Images At Home By Lay Users

Product code

SGJ

Device name

Ultrasound Imaging System For Acquiring Images At Home By Lay Users

Device class

Class 2

21 CFR

21 CFR 892.1590

Medical specialty

Radiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-10-31.