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X-ray system, diagnostic, dental, general-purpose, application program software - ARTG 481005

Access comprehensive regulatory information for X-ray system, diagnostic, dental, general-purpose, 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 481005 and sponsored by Freyr Australia Pty Ltd, manufactured by DGNCT LLC in United States of America. The device registration started on February 27, 2025.

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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Class IIa
ARTG 481005
Class IIa
X-ray system, diagnostic, dental, general-purpose, application program software
ARTG ID: 481005
Good Name: Freyr Australia Pty Ltd - X-ray system, diagnostic, dental, general-purpose, application program software
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Intended Purpose

The Diagnocat AIS automated information system is designed for cloud-based storage and processing of digital dental images using artificial intelligence. Diagnocat AIS has been developed to automate the activities of dental organizations in radiological examinations, including examination uploading, screening of diagnostic images, saving, sharing, editing and drawing conclusions. Diagnocat AIS processes files of any area of the patient's maxillofacial region. Diagnocat AIS is designed for use by medical professionals (dentists, orthodontists, radiologists, etc.) for education purposes and highlights anatomical areas, common conditions and previous treatments. DiagnocatAIS automatically produces radiological reports for easier viewing and documentation of investigation for a particular patient. Diagnocat AIS can also be used by managers and administrators of clinics to document patient treatment history and maintain personal records. This is a reusable, non-invasive device for image processing and documentation. The Software cannot be used to make a decision about the diagnosis, presence or absence of a disease on the basis of the online screening, without additional investigation. The Software cannot be used for direct diagnosis and clinical decision making.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
481005
Start Date
February 27, 2025
Effective Date
February 27, 2025
Manufacturer
Country
United States of America
Address
333 SE 2nd Avenue 20th Floor #563, Miami, Florida, 33131