FDA-cleared K252421

JLK-NCCT

JLK, Inc.

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
Decision
2026-03-24
FDA-cleared K251983

Brainomix 360 Triage Stroke

Brainomix Limited

Triage and notification of suspected intracranial hemorrhage or anterior-circulation LVO on acute non-contrast head CT; not primary diagnosis.

Modality
CT/CTA
Anatomy
Brain/head, including intracranial ICA and M1 for LVO and intracranial hemorrhage findings
Decision
2025-08-26
FDA-cleared K251590

Methinks CTA Stroke

Methinks Software S.L.

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...

Modality
CT/CTA
Anatomy
Brain
Decision
2025-08-20
FDA-cleared K250685

Methinks NCCT Stroke

Methinks Software S.L.

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...

Modality
CT/CTA
Anatomy
Brain
Decision
2025-06-16
FDA-cleared K250831

Annalise Enterprise

Annalise-AI

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
Anatomy
Chest/Lung; Brain
Decision
2025-04-23
FDA-cleared K243611

JLK-SDH

JLK, Inc.

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...

Modality
CT/CTA
Anatomy
Head
Decision
2025-03-03
FDA-cleared K240712

icobrain aria

icometrix NV

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,...

Modality
MRI
Anatomy
Brain
Decision
2024-11-07
FDA-cleared K241719

NeuroICH

Neurocareai Inc.

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.
Decision
2024-11-07
FDA-cleared K241480

JBS-LVO

JLK, Inc.

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
Decision
2024-09-27
FDA-cleared K242292

uAI Easy Triage ICH

Shanghai United Imaging Intelligence Co., Ltd.

Assist hospital networks and trained radiologists with workflow triage by flagging and prioritizing non-enhanced head CT studies with suspected intracranial hemorrhage.

Modality
CT/CTA
Anatomy
Head/brain; intracranial hemorrhage
Decision
2024-09-24
FDA-cleared K233247

Heuron ICH

Heuron Co., Ltd.

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...

Modality
CT/CTA
Anatomy
Head/brain
Decision
2024-05-15
FDA-cleared K233582

Rapid

iSchema View Inc.

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
Decision
2024-04-22
FDA-cleared K232431

syngo.CT Brain Hemorrhage

Siemens Medical Solutions USA, Inc.

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
Decision
2024-03-22
FDA-cleared K232363

Viz HDS, Viz Volume Plus, Viz ICH+

Viz.ai, Inc.

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)
Decision
2024-02-05
FDA-cleared K232156

Rapid ASPECTS (v3)

iSchemaView, Inc.

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

Modality
CT/CTA
Anatomy
Brain/head ASPECTS regions
Decision
2024-01-19
FDA-cleared K233512

Rapid (6.0)

iSchemaView, Inc.

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
Decision
2024-01-16
FDA-cleared K232496

Brainomix 360 Triage Stroke

Brainomix Limited

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
Decision
2023-11-21
FDA-cleared K232436

Rapid SDH

iSchemaView, Inc.

Triage and notification of suspected hemispheric subdural hemorrhage (SDH) on non-enhanced head CT, in parallel with standard-of-care interpretation; not diagnostic.

Modality
CT/CTA
Anatomy
Head, specifically hemispheric subdural space
Decision
2023-10-25
FDA-cleared K221716

CINA

AVICENNA.AI

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...

Modality
CT/CTA
Anatomy
Brain
Decision
2022-11-22
FDA-cleared K221456

Rapid ICH

iSchemaView Inc.

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.
Decision
2022-09-12
FDA-cleared K220439

Viz SDH

Viz.ai, Inc.

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,...

Modality
CT/CTA
Anatomy
Brain
Decision
2022-07-25
FDA-cleared K213165

Rapid

iSchema View Inc.

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
Anatomy
Brain
Decision
2022-02-08
FDA-cleared K203260

syngo.CT Brain Hemorrhage

Siemens Medical Solutions USA, Inc.

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...

Modality
CT/CTA
Anatomy
Brain
Decision
2022-01-28
FDA-cleared K212116

VBrain-OAR

Vysioneer Inc.

VBrain-OAR provides the cleared image-processing and organ-at-risk contouring support described in K212116 for brain radiotherapy planning, with all contours requiring...

Modality
Radiotherapy Planning Imaging
Anatomy
Brain and intracranial organs at risk
Decision
2021-10-12
FDA-cleared K211222

qER-Quant

Qure.ai Technologies

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
Decision
2021-07-30
FDA-cleared K211788

HALO

Nico.Lab B.V.

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...

Modality
CT/CTA
Anatomy
Brain
Decision
2021-07-08
FDA-cleared K210209

Viz ICH

Viz.ai, Inc.

Notification-only, parallel workflow tool for hospital networks and trained clinicians that analyzes acute non-contrast brain CT and communicates suspected intracranial hemorrhage...

Modality
CT/CTA
Anatomy
Head/brain; suspected intracranial hemorrhage.
Decision
2021-03-23
FDA-cleared K203508

BriefCase

Aidoc Medical, Ltd.

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
Decision
2020-12-29
FDA-cleared K200873

HALO

NICo-Lab B.V.

HALO analyzes contrast-enhanced brain CTA in the acute setting for suspected anterior-circulation large-vessel occlusion and provides notification support for emergency stroke...

Modality
CT/CTA
Anatomy
Brain
Decision
2020-11-20
FDA-cleared K193289

FastStroke, CT Perfusion 4D

GE Medical Systems SCS

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...

Modality
CT/CTA
Anatomy
Brain
Decision
2020-11-12
FDA-cleared K200750

Neuro.Al Algorithm

TeraRecon, Inc.

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
Anatomy
Brain and intracranial perfusion regions
Decision
2020-11-06
FDA-cleared K201310

Accipiolx

MaxQ Al Ltd.

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...

Modality
CT/CTA
Anatomy
Brain
Decision
2020-08-07
FDA-cleared K200760

Rapid ASPECTS

iSchemaView Inc.

Adjunct evaluation of extent of early ischemic brain injury in patients with known MCA or ICA occlusion during stroke imaging interpretation within 6 hours

Modality
CT/CTA
Anatomy
Brain/head ASPECTS regions
Decision
2020-06-26
FDA-cleared K200921

qER

Qure.ai Technologies

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...

Modality
CT/CTA
Anatomy
Brain
Decision
2020-06-17
FDA-cleared K192167

CuraRad-ICH

CuraCloud Corp.

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...

Modality
CT/CTA
Anatomy
Brain
Decision
2020-04-13
FDA-cleared K193087

Rapid ICH

iSchemaView Incorporated

Notification-only triage of adult noncontrast head CT for suspected intracranial hemorrhage; results do not replace diagnostic interpretation.

Modality
CT/CTA
Anatomy
Brain
Decision
2020-03-31
FDA-cleared K193658

Viz ICH

Viz.ai, Inc.

Notification-only triage of adult noncontrast head CT for suspected intracranial hemorrhage, with specialist notification; results do not replace diagnostic interpretation.

Modality
CT/CTA
Anatomy
Brain
Decision
2020-03-18
FDA-cleared K182875

DeepCT

Deep01 Limited

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.
Decision
2019-07-10
FDA-cleared K190424

HealthICH

Zebra Medical Vision Ltd.

Case-level triage of adult non-contrast head CT examinations with features suggestive of intracranial hemorrhage (ICH); not a diagnostic or rule-out tool.

Modality
CT/CTA
Anatomy
Head/brain
Decision
2019-06-13
FDA-cleared K182130

iSchemaView RAPID

iSchemaView, Inc.

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
Decision
2018-12-27
FDA-cleared K182177

Accipiolx

MaxQ-Al Ltd.

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
Decision
2018-10-26
FDA-cleared K180647

BriefCase

Aidoc Medical, Ltd.

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...

Modality
CT/CTA
Anatomy
Brain
Decision
2018-08-01
FDA-cleared K173939

Quantib Brain

Quantib BV

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
Decision
2018-03-09