Australia TGA ARTG record

Embrace Neonatal MRI System - MRI system, full-body, permanent magnet

Australia TGA ARTG Registered Device · Gamma Gurus Pty Ltd · Aspect Imaging Ltd · Class IIa · Started February 15, 2023

Good Name: Gamma Gurus Pty Ltd - Embrace Neonatal MRI System - MRI system, full-body, permanent magnet

Device classification

Risk Class: Class IIa
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: February 15, 2023
Effective Date: February 15, 2023

Sponsor

Name: Gamma Gurus Pty Ltd

Manufacturer

Name: Aspect Imaging Ltd
Country: Israel
Address: 27 Shaked Street Industrial Area, Hevel Modi'in, 7319900

Intended purpose

The Embrace Neonatal MRI System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that displays the internal structure of neonatal head with circumference of up to 38cm and weight between 1Kg and 4.5 Kg. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

About this record

Access comprehensive regulatory information for Embrace Neonatal MRI System - MRI system, full-body, permanent magnet in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Gamma Gurus Pty Ltd, manufactured by Aspect Imaging Ltd in Israel. The device registration started on February 15, 2023.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.