ARTG 462546X-ray system, diagnostic, computed tomography, limited view field
ARTG ID: 462546 · CurveBeam AI Limited · CurveBeam LLC · Class IIb · Started September 23, 2024
Good Name: CurveBeam AI Limited - X-ray system, diagnostic, computed tomography, limited view field
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 462546
- Start Date
- September 23, 2024
- Effective Date
- September 23, 2024
- Name
- CurveBeam LLC
- Country
- United States of America
- Address
- 2800 Bronze Drive Suite 110, Hatfield, Pennsylvania, 19440
The HiRise is intended to be used for 3‐D imaging of the upper and the lower extremities and pelvis of adult and pediatric patients weighing from 40 to 450 lbs. The device is to be operated in a professional healthcare environment by qualified health care professionals only.
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 462546 and sponsored by CurveBeam AI Limited, manufactured by CurveBeam LLC in United States of America. The device registration started on September 23, 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.