| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00860011623908 [Primary] |
| QIH | Automated Radiological Image Processing Software |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-30 |
| Device Publish Date | 2024-05-22 |
| 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 |