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X-ray system, diagnostic, computed tomography, limited view field - ARTG 472005

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 registered under ARTG number 472005 and sponsored by CurveBeam AI Limited, manufactured by CurveBeam LLC in United States of America. The device registration started on December 06, 2024.

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.

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TGA ARTG Official Data
Class IIb
ARTG 472005
Class IIb
X-ray system, diagnostic, computed tomography, limited view field
ARTG ID: 472005
Good Name: CurveBeam AI Limited - X-ray system, diagnostic, computed tomography, limited view field
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Intended Purpose

The InReach is intended to be used for 3-D imaging of the hand, wrist, elbow, knee, foot, and ankle regions, to visualize and assess the osseous and certain soft tissue structures, including joint spaces, bone angles and fractures. This modality is anticipated to be applicable to pediatric* cases as well as adults*, when appropriate diagnosis of a given hand, wrist, elbow, knee, foot or ankle condition is considered necessary. * Patient parameters: 50lbs to 400lbs

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
472005
Start Date
December 06, 2024
Effective Date
December 06, 2024
Manufacturer
Country
United States of America
Address
2800 Bronze Drive Suite 110, Hatfield, Pennsylvania, 19440