Notification-only triage of adult non-contrast head CT for suspected intracranial hemorrhage and large-vessel occlusion, with parallel communication to trained clinicians during...
Modality
CT/CTA
Anatomy
Brain and intracranial vessels: intracranial hemorrhage and LVO involving ICA, MCA-M1, and MCA-M2
Methinks CTA Stroke analyzes acute-setting brain CT angiography in adults over 21 with suspected stroke for suspected large-vessel occlusion in the terminal ICA, MCA-M1, or MCA-M2...
Rapid CTA 360 analyzes adult head CTA DICOM images to flag suspected large- and medium-vessel occlusion in specified intracranial and vertebral segments and notify trained...
Methinks NCCT Stroke analyzes adult non-contrast head CT to flag suspected intracranial hemorrhage and suspected large-vessel occlusion of the ICA, MCA-M1, or MCA-M2 for parallel...
Triage and prioritization of adult CXR and non-contrast brain CT studies for specified suspected findings, including pneumoperitoneum, pleural effusion, pneumothorax and tension...
Modality
Radiological images; modality varies or is not specified in FDA list
JLK-SDH analyzes non-contrast head CT for suspected hemispheric subdural hemorrhage and sends notification to a clinician for review in parallel to standard care; PACS/mobile...
Brainomix 360 e-ASPECTS registers adult non-contrast brain CT, segments ASPECTS regions, and provides an editable ASPECTS score with highlighted regions and voxel contribution...
icobrain aria is a computer-assisted detection (CADe) and diagnosis (CADx) software device to be used as a concurrent reading aid to help trained radiologists in the detection,...
Notify hospital-network clinicians and neurovascular or neurosurgical specialists of suspected ICH on acute non-contrast head CT in parallel with standard-of-care interpretation;...
Modality
CT/CTA
Anatomy
Brain, with intracranial hemorrhage (ICH) subtypes including extradural, subdural, subarachnoid, intraparenchymal, and intraventricular hemorrhage.
Notification-only parallel workflow analysis of acute brain CTA to identify suspected large-vessel occlusion in the terminal ICA or MCA-M1 and notify a neurovascular specialist...
Modality
CT/CTA
Anatomy
Brain; terminal intracranial ICA and MCA-M1 vessels
Assist hospital networks and trained radiologists with workflow triage by flagging and prioritizing non-enhanced head CT studies with suspected intracranial hemorrhage.
Notification-only triage for suspected acute intracranial hemorrhage on non-contrast brain CT, sharing cases with medical specialists in parallel with standard care.
Triage and notification of suspected intracranial hemorrhage on non-contrast head CT in adults and transitional adolescents aged 18 years and older, to assist prioritization while...
Rapid is image-viewing, processing, and analysis software for DICOM CT, CT perfusion, CT angiography, C-arm CT perfusion, and MRI data, including perfusion maps and acute-stroke...
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Brain, cerebral vasculature, and perfusion regions
Assist radiologists in prioritizing suspected intracranial hemorrhage, including subarachnoid hemorrhage, on non-contrast head CT through case-level worklist output; the output is...
Modality
CT/CTA
Anatomy
Head/brain, including intracranial and subarachnoid spaces
Automatically label, visualize, and quantify segmentable brain structures on single-time-point non-contrast head CT, including intracranial hyperdensities, lateral ventricles, and...
Modality
CT/CTA
Anatomy
Brain (intracranial hyperdensities, lateral ventricles, and midline shift)
Adjunct assessment of early ischemic brain tissue injury and extent of disease in adult ischemic-stroke diagnostic imaging workup, typically within 24 hours of last known well
Rapid Platform v6.0 is image-processing software for trained professionals that views, processes, and analyzes DICOM images from CT and MRI. It supports functional and dynamic...
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Brain and intracranial vessels represented in CT perfusion, CTA, and MRI; tissue perfusion, diffusion, and contrast dynamics
Provide quantitative perfusion information in brain tissue for suspected ischemic stroke patients using dynamic brain CT perfusion studies; medical imaging professionals use the...
Analyze non-contrast head CT images to help hospital networks and trained clinicians triage and prioritize suspected positive findings for intracranial ICA/M1 large-vessel...
Modality
CT/CTA
Anatomy
Head/brain; intracranial ICA and M1 for LVO and intracranial hemorrhage
Triage and notification of suspected hemispheric subdural hemorrhage (SDH) on non-enhanced head CT, in parallel with standard-of-care interpretation; not diagnostic.
Case-level prioritization and passive notification for adult non-contrast head CT studies with features suggestive of acute intracranial hemorrhage (ICH); not a stand-alone...
Assist hospital networks and trained radiologists in routine-care workflow triage by flagging and prioritizing adult studies with suspected unruptured saccular brain aneurysms at...
Provide notification-only parallel workflow triage of adult non-contrast brain CT studies acquired in the acute setting within 24 hours of symptom onset or since last known well...
Intended Context Annalise Triage is a device designed to be used in the medical care environment to aid in triage and prioritization of studies with features suggestive of the...
Intended Context Annalise Triage is a device designed to be used in the medical care environment to aid in triage and prioritization of studies with features suggestive of the...
Rapid NCCT Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of (1) nonenhanced head CT (NCCT) images. The device is...
Brainomix 360 e-ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities...
CINA analyzes non-enhanced head CT and head CTA DICOM in parallel with standard interpretation to flag suspected intracranial hemorrhage and anterior-circulation large-vessel...
Assist hospital networks and trained radiologists with workflow triage by flagging and communicating suspected IPH, IVH, SAH, and SDH findings in non-enhanced head CT images.
Modality
CT/CTA
Anatomy
Head/brain; suspected intraparenchymal, intraventricular, subarachnoid, and subdural intracranial hemorrhage.
Viz SDH is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist,...
Assist hospital networks and trained radiologists with workflow triage by flagging and communicating suspected ICA or MCA-M1 large-vessel occlusion findings in head CTA images.
Modality
CT/CTA
Anatomy
Head/brain vasculature, specifically the intracranial ICA and MCA-M1 segments.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of nonenhanced head CT images in adults or transitional adolescents...
Intended Context Annalise Triage is a device designed to be used in the medical care environment to aid in triage and prioritization of studies with features suggestive of the...
Rapid processes CT, CTP, CTA, diffusion MRI, and dynamic-contrast MRI for stroke viewing, perfusion, volumetry, mismatch, and large-vessel-density support for trained...
Modality
Radiological images; modality varies or is not specified in FDA list
Intracranial hemorrhage on non-contrast CT examinations of the head. It makes case-level output available to a CT scanner or other PACS system for worklist prioritization. The...
Stroke SENS LVO is a radiological computer-aided triage and notification (CADt) software indicated for use in the analysis of CTA head images. The device is intended to assist...
VBrain-OAR provides the cleared image-processing and organ-at-risk contouring support described in K212116 for brain radiotherapy planning, with all contours requiring...
InferRead CT Stroke.AI is a radiological computer aided triage and notification software for use in the analysis of Non-Enhanced Head CT images. The device is intended to assist...
Automatic labeling, visualization, and quantification of segmentable brain structures from non-contrast head CT, including intracranial hyperdensities, lateral ventricles, and...
Modality
CT/CTA
Anatomy
Brain; intracranial hyperdensities, lateral ventricles, and midline shift
HALO is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to the standard...
BriefCase analyzes supported noncontrast head CT, head CTA, noncontrast cervical-spine CT, and CTPA examinations to triage suspected intracranial hemorrhage, large-vessel...
Modality
CT/CTA
Anatomy
Adult head, brain, cervical spine, pulmonary arteries, and thorax
HALO analyzes contrast-enhanced brain CTA in the acute setting for suspected anterior-circulation large-vessel occlusion and provides notification support for emergency stroke...
FastStroke is a CT image analysis software package that assists in the analysis and visualization of CT data derived from DICOM 3.0 compliant CT scans. FastStroke is intended for...
Neuro.Al Algorithm processes static, functional, dynamic, and derived CT or MR images to support brain perfusion analysis, tissue blood-volume and parametric-map review,...
Modality
Radiological images; modality varies or is not specified in FDA list
AccipioIx is a software workflow tool designed to aid in prioritizing the clinical assessment of adult non-contrast head CT cases with features suggestive of acute intracranial...
Adjunct evaluation of extent of early ischemic brain injury in patients with known MCA or ICA occlusion during stroke imaging interpretation within 6 hours
CINA analyzes nonenhanced head CT for suspected intracranial hemorrhage and head CTA for suspected large-vessel occlusion for computer-aided triage and notification in parallel...
qER is a radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT images. The device is intended to assist hospital...
CuraRad-ICH is a software workflow tool designed to aid in prioritizing the clinical assessment of adult non-contrast head CT cases with features suggestive of acute intracranial...
Notification-only triage of adult noncontrast head CT for suspected intracranial hemorrhage, with specialist notification; results do not replace diagnostic interpretation.
Notification-only, parallel-workflow triage that identifies and communicates acute non-contrast brain CT studies with suspected ICH to a specialist for image review; not for...
Modality
CT/CTA
Anatomy
Brain, for suspected intracranial hemorrhage and/or hematoma.
Case-level triage of adult non-contrast head CT examinations with features suggestive of intracranial hemorrhage (ICH); not a diagnostic or rule-out tool.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced CT and CTPA images. The device is intended to assist...
iSchemaView RAPID processes CT perfusion, CTA, and MR studies to visualize and analyze diffusion and perfusion, including tissue blood-volume maps, and supports physician...
Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Brain, intracranial vasculature, and perfusion regions
Accipiolx prioritizes adult noncontrast head CT studies for cases with acute intracranial hemorrhage by sending studies from PACS to an analysis engine and returning case-level...
Modality
CT/CTA
Anatomy
Adult head and brain; acute intracranial hemorrhage
BriefCase provides computer-assisted triage and notification for suspected intracranial hemorrhage on noncontrast head CT and or large-vessel occlusion on head CTA in parallel...
Automatic brain-structure labeling, visualization, volumetric quantification, and WMH-candidate assessment as complementary information for trained professionals evaluating MR...
Modality
MRI
Anatomy
Brain structures including grey matter, white matter, cerebrospinal fluid, intracranial volume, and white matter hyperintensity candidates