iQ-solutions™

GUDID 00860011623908

iQ-solutions™ is a software medical device intended for automatic annotation, visualization, and quantification of segmentable brain structures from a set of brain MRI scans. It is intended to accelerate and improve the quantification of brain structures that would otherwise require a manual process of identifying, annotating, and measuring regions of interest in brain MRI scans. iQ-solutions™ consists of both cross-sectional and longitudinal analysis pipelines. • The cross-sectional pipeline is intended to conduct structure segmentation and volume analysis on brain MRI scans at a single time point. • The longitudinal pipeline is intended to conduct volume change analysis on a single patient’s MRI scans acquired on the same scanner, with consistent image acquisition protocol and with consistent contrast at two different time points. The results of the cross-sectional pipeline cannot be compared with the results of the longitudinal pipeline.

SYDNEY NEUROIMAGING ANALYSIS CENTRE PTY LTD

Radiology DICOM image processing application software

• Primary Device ID: 00860011623908
• NIH Device Record Key: d73a2b72-f47d-437c-9373-36c502ffd252
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iQ-solutions™
• Version Model Number: 1.12.6
• Company DUNS: 746985634
• Company Name: SYDNEY NEUROIMAGING ANALYSIS CENTRE PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	00860011623908 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231929

FDA Product Code

• QIH: Automated Radiological Image Processing Software

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™: 2024-05-30iQ-solutions™ is a software medical device intended for automatic annotation, visualization, and quantification of segmentable brain structures from a set of brain MRI scans. It is intended to accelerate and improve the quantification of brain structures that would otherwise require a manual process of identifying, annotating, and measuring regions of interest in brain MRI scans. iQ-solutions™ consists of both cross-sectional and longitudinal analysis pipelines. • The cross-sectional pipeline is intended to conduct structure segmentation and volume analysis on brain MRI scans at a single time point. • The longitudinal pipeline is intended to conduct volume change analysis on a single patient’s MRI scans acquired on the same scanner, with consistent image acquisition protocol and with consistent contrast at two different time points. The results of the cross-sectional pipeline cannot be compared with the results of the longitudinal pipeline.
• 00860011623908 - iQ-solutions™: 2024-05-30 iQ-solutions™ is a software medical device intended for automatic annotation, visualization, and quantification of segmentable
• 00860011623915 - Torana™: 2024-05-30 The Torana™ Medical Imaging Gateway is a software product that manages the routing of medical image files or related health in