Product code SGJ

Device name

Ultrasound Imaging System For Acquiring Images At Home By Lay Users

Medical specialty

Radiology

Device class

2

Regulation number

892.1590

Review panel

RA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset