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X-ray system, diagnostic, dental, general-purpose, application program software - ARTG 431462

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 I is registered under ARTG number 431462 and sponsored by Freyr Australia Pty Ltd, manufactured by DGNCT LLC in United States of America. The device registration started on December 20, 2023.

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 I
ARTG 431462
Class I
X-ray system, diagnostic, dental, general-purpose, application program software
ARTG ID: 431462
Good Name: Freyr Australia Pty Ltd - X-ray system, diagnostic, dental, general-purpose, application program software
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Intended Purpose

The Diagnocat AI automated information system is designed for cloud-based storage and processing of digital dental images using artificial intelligence. Diagnocat AI 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 AI processes files of any area of the patient's maxillofacial region. Diagnocat AI is designed for use by medical professionals (dentists, orthodontists, radiologists, etc.) for education purposes and highlights anatomical areas, common conditions, and previous treatments. Diagnocat AI automatically produces radiological reports for easier viewing and documentation of investigation for a particular patient. Diagnocat AI 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 I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
431462
Start Date
December 20, 2023
Effective Date
December 20, 2023
Manufacturer
Country
United States of America
Address
333 SE 2nd Avenue 20th Floor #563, Miami, Florida, 33131