Neurovascular Insight V1.0

Neurovascular Insight V1.0 is an optional user interface for viewing and processing neurological DICOM medical images (MR and CT studies) on a compatible technical integration environment. It allows trained medical professionals to display images, edit and modify processing parameters, and confirm/export outputs from compatible applications without altering the original image data. The device is not intended as a diagnostic tool but to assist clinicians in medical imaging assessment.

Both the subject device and predicate provide identical core tools: MR and CT image loading and visualization, standard viewing tools, 3D MIP visualization, manual side selection, and manual AIF/VOF selection. The minor difference is that Neurovascular Insight V1.0 adds the capability to manually select ASPECTS regions and confirm information before displaying outputs and exporting them—a feature already cleared in the reference CINA-ASPECTS device for the same intended use.

Not stated in this summary.

Substantial equivalence is supported by three factors: (1) substantially equivalent intended use—both devices visualize MR and CT studies and allow parameter editing in clinical environments by trained professionals; (2) equivalent technological characteristics—both provide the same core viewing and editing tools, with the subject device's added confirmation feature already validated in a cleared reference device; and (3) adequate verification and validation testing—internal software testing, risk assessment, and usability testing confirmed the subject device meets specifications and performs comparably to the predicate, with no new safety or effectiveness questions raised by the minor technological differences.