Ultrasound Imaging System For Acquiring Images At Home By Lay Users

SGJ · Class II — Moderate Risk (510(k) clearance required) · Radiology · 21 CFR 892.1590

Classification

FDA Product Code: SGJ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 892.1590
Review panel: RA
Medical specialty: Radiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown