iQ-solutions™
SYDNEY NEUROIMAGING ANALYSIS CENTRE PTY LTD · Model 1.12.6 · UDI-DI 00860011623908
Description
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-07 | PIE Medical Imaging B.V. | User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical d |
| 2021-05-19 | Caption Health | The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect automated ejection fraction (AutoE |
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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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