Torana™

GUDID 00860011623915

The Torana™ Medical Imaging Gateway is a software product that manages the routing of medical image files or related health informatics. Torana™ Medical Imaging Gateway can be configured by the users to facilitate custom data workflows that integrate PACS, RIS, databases, and image analysis services. Example usages of Torana™ Medical Imaging Gateway include the automatic routing/archiving of newly acquired medical scans or the submission of medical scans for AI analysis to a remote cloud server.

SYDNEY NEUROIMAGING ANALYSIS CENTRE PTY LTD

Radiological PACS software

• Primary Device ID: 00860011623915
• NIH Device Record Key: 6647ee13-34db-4b89-9bd9-a6f41ec17687
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Torana™
• Version Model Number: 2.18.2
• Company DUNS: 746985634
• Company Name: SYDNEY NEUROIMAGING ANALYSIS CENTRE PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011623915 [Primary]

FDA Product Code

• LMD: System, Digital Image Communications, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-30
• Device Publish Date: 2024-05-22

Devices Manufactured by SYDNEY NEUROIMAGING ANALYSIS CENTRE PTY LTD

• 00860011623908 - iQ-solutions™: 2024-05-30 iQ-solutions™ is a software medical device intended for automatic annotation, visualization, and quantification of segmentable
• 00860011623915 - Torana™: 2024-05-30The Torana™ Medical Imaging Gateway is a software product that manages the routing of medical image files or related health informatics. Torana™ Medical Imaging Gateway can be configured by the users to facilitate custom data workflows that integrate PACS, RIS, databases, and image analysis services. Example usages of Torana™ Medical Imaging Gateway include the automatic routing/archiving of newly acquired medical scans or the submission of medical scans for AI analysis to a remote cloud server.
• 00860011623915 - Torana™: 2024-05-30 The Torana™ Medical Imaging Gateway is a software product that manages the routing of medical image files or related health in