Vendor
10 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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Viz.ai, Inc.
Authorized purpose: Viz Subdural+ labels, visualizes, and quantifies subdural collections from single-time-point non-contrast head CT, reporting collection grayscale value, total volume, widest width, and midline shift as annotated DICOM images for physician review with original CT.
Viz.ai, Inc.
Authorized purpose: Automatically label, visualize, and quantify segmentable brain structures on single-time-point non-contrast head CT, including intracranial hyperdensities, lateral ventricles, and midline shift; output must be reviewed with the original images by a physician.
Viz. ai, Inc.
Authorized purpose: Provides computer-assisted triage and notification for CTA abdomen studies with suspected abdominal aortic aneurysms.
Viz.ai, Inc.
Authorized purpose: Notification-only parallel workflow to identify and communicate suspected large vessel occlusion on acute brain CTA to a neurovascular specialist; identification is not for diagnosis beyond notification.
Viz.ai, Inc.
Authorized purpose: Measures maximal right- and left-ventricular diameters from volumetric CTPA and reports their ratio.
Viz.ai, Inc.
Authorized purpose: Notification-only parallel workflow for identifying and communicating images of patients with suspected subdural hemorrhage from non-contrast head CT to neurovascular or neurosurgical specialists; not diagnostic beyond notification.
Viz.ai, Inc.
Authorized purpose: Triage and notification of suspected head aneurysms during routine care; not a diagnostic device.
Viz.ai, Inc.
Authorized purpose: Notification-only, parallel workflow tool for hospital networks and trained clinicians that analyzes acute non-contrast brain CT and communicates suspected intracranial hemorrhage to a neurovascular or neurosurgical specialist for review.
Viz.ai, Inc.
Authorized purpose: Notification-only triage of adult noncontrast head CT for suspected intracranial hemorrhage, with specialist notification; results do not replace diagnostic interpretation.
Viz.ai, Inc.
Authorized purpose: Image processing, analysis, and communication of dynamic brain CT perfusion datasets to calculate perfusion parameters for review by trained professionals.