Australia TGA ARTG record

X-ray system, diagnostic, computed tomography, limited view field

Australia TGA ARTG Registered Device · Australian Imaging · CurveBeam LLC · Class IIb · Started December 18, 2020

Good Name: Australian Imaging - X-ray system, diagnostic, computed tomography, limited view field

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: December 18, 2020
Effective Date: December 18, 2020

Sponsor

Name: Australian Imaging

Manufacturer

Name: CurveBeam LLC
Country: United States of America
Address: 2800 Bronze Drive Hatfield, ., Pennsylvania, 19440

Intended purpose

The HiRise is intended to be used for 3D imaging of the foot, ankle, knee and hip regions, to visualise and assess the osseous and certain soft tissue structures, including joint spaces, bone angles and fractures. This modality is anticipated to be used when appropriate diagnosis of a given condition is considered necessary.

About this record

Access comprehensive regulatory information for X-ray system, diagnostic, computed tomography, limited view field in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Australian Imaging, manufactured by CurveBeam LLC in United States of America. The device registration started on December 18, 2020.

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.