ARTG 481886

Laboratory information system IVDs

ARTG ID: 481886 · Fujifilm Australia Pty Ltd · Fujifilm Healthcare Americas Corporation · Class IIa · Started March 06, 2025

Good Name: Fujifilm Australia Pty Ltd - Laboratory information system IVDs

Device classification

Risk Class: Class IIa
Product Type: IVD
ARTG Category: IVD

Registration information

ARTG ID: 481886
Start Date: March 06, 2025
Effective Date: March 06, 2025

Sponsor

Name: Fujifilm Australia Pty Ltd

Manufacturer

Name: Fujifilm Healthcare Americas Corporation
Country: United States of America
Address: 81 Hartwell Avenue Suite 300 Lexington, Massachusetts, 02421

Intended purpose

Synapse Pathology Digital Pathology Software (Synapse Pathology) is a qualitative medical device intended for ingesting, viewing, and management of scanned (digitized) surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue and associated case data. For the pathologist, Synapse Pathology displays consolidated patient case data and digital images to facilitate diagnosis for pathology. Synapse Pathology is used in a clinical laboratory and/or a pathologists’ office. When viewing digital images, pathologists manually pan, zoom, and annotate digital images. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images and associated case data when using Synapse Pathology.

About this record

Access comprehensive regulatory information for Laboratory information system IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 481886 and sponsored by Fujifilm Australia Pty Ltd, manufactured by Fujifilm Healthcare Americas Corporation in United States of America. The device registration started on March 06, 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.