ARTG 381253X-ray system, diagnostic, computed tomography, application program software
ARTG ID: 381253 · KD & A Pty Ltd · Circle Cardiovascular Imaging Inc · Class IIa · Started December 22, 2021
Good Name: KD & A Pty Ltd - X-ray system, diagnostic, computed tomography, application program software
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 381253
- Start Date
- December 22, 2021
- Effective Date
- December 22, 2021
- Name
- KD & A Pty Ltd
- Country
- Canada
- Address
- Suite 1100 800 5th Avenue SW, Calgary, Alberta, T2P 3T6
TruPlan enables visualization and measurement of structures of the heart and vessels for: • Pre-procedural planning and sizing for the left atrial appendage closure (LAAC) procedure • Post-procedural evaluation for the LAAC procedure To facilitate the above, TruPlan provides general functionality such as: • Segmentation of cardiovascular structures • Visualization and image reconstruction techniques: 2D review, Volume Rendering, MPR • Simulation of TEE views, ICE views, and fluoroscopic rendering • Measurement and annotation tools • Reporting tools TruPlan’s intended patient population is comprised of adult patients.
Access comprehensive regulatory information for X-ray system, diagnostic, computed tomography, application program software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 381253 and sponsored by KD & A Pty Ltd, manufactured by Circle Cardiovascular Imaging Inc in Canada. The device registration started on December 22, 2021.
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.