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 Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software 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