X-ray system, diagnostic, dental, panoramic/tomographic, application program software - ARTG 474385
Access comprehensive regulatory information for X-ray system, diagnostic, dental, panoramic/tomographic, application program software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 474385 and sponsored by Henry Schein Halas, manufactured by Planmeca Oy in Finland. The device registration started on December 20, 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.
Planmeca Romexis is a medical imaging software intended for use in dental and medical care as a tool for displaying and visualizing dental and medical 2D and 3D image files from imaging devices, such as projection radiography and CBCT. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, diagnose, review, store, print, and distribute images of both adult and pediatric patients. Planmeca Romexis is also a preoperative software used for dental implant planning. Based on the planned implant position a model of a surgical guide for a guided implant surgery can be designed. The designed objects can be exported to manufacture a separate physical product. Planmeca Romexis is also a preoperative software for simulating / evaluating surgical treatment options. Based on the simulation, models, guides and splints can be designed for use in maxillofacial surgery. The designed objects can be exported to manufacture a separate physical product. Additionally, Planmeca Romexis includes monitoring features for Planmeca devices for maintenance purposes. The software is designed to work as a stand-alone or as an accessory to Planmeca imaging and Planmeca dental unit products in standard PC. The software is for use by authorized healthcare professionals. Use of the software for implant planning requires that the user has the necessary medical training in implantology and surgical dentistry. Use of the software for surgical treatment planning requires that the user has the necessary medical training in maxillofacial surgery.