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

Risk Class

Class IIa

Product Type

Single Device Product

ARTG Category

General

ARTG ID

481005

Start Date

February 27, 2025

Effective Date

February 27, 2025

Name

Freyr Australia Pty Ltd

Name

DGNCT LLC

Country

United States of America

Address

333 SE 2nd Avenue 20th Floor #563, Miami, Florida, 33131

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.