FDA-cleared K260729

Vascular Assist Occlusion Triage (VAOT) (v1.0)

GuideAI Health

Passive workflow prioritization for studies with imaging patterns consistent with possible total arterial occlusion in the specified vessels; not primary diagnosis, screening,...

Modality
CT/CTA
Anatomy
Aorta and lower-extremity arteries: common iliac, external iliac, common femoral, superficial femoral, and popliteal arteries
Decision
2026-06-18
FDA-cleared K261317

BriefCase-Triage

Aidoc Medical, Ltd.

Adult head CTA or mCTA triage for suspected complete large-vessel and medium-vessel occlusion.

Modality
CT/CTA
Anatomy
Head/Brain
Decision
2026-05-14
FDA-cleared K252954

MammoSightAI

Neurocareai, Inc. (Dba Savelife.Ai)

Tags screening cases as suspicious or blank to aid worklist prioritization; radiologists must review every examination and it does not mark original images.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2026-05-04
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 K253818

Annalise Enterprise

Harrison-AI Medical Pty, Ltd.

Annalise Enterprise prioritizes and notifies trained CT clinicians of suspected acute infarct on non-contrast brain CT for adults; it is a study-level, non-localizing worklist aid...

Modality
CT/CTA
Anatomy
Brain
Decision
2026-03-03
FDA-cleared K253578

BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device

Aidoc Medical, Ltd.

BriefCase-Triage CARE Multi-Triage CT analyzes contrast and non-contrast chest, abdomen, or chest/abdomen CT in adults or transitional adolescents aged 18 and older to flag...

Modality
CT/CTA
Anatomy
Chest and abdomen; pneumothorax, pericardial effusion, large aortic aneurysm, and shoulder fracture/dislocation
Decision
2026-02-26
FDA-cleared K251195

BriefCase-Triage

Aidoc Medical, Ltd.

Adult contrast-enhanced brain CT triage for suspected brain aneurysm findings at least 3.0 mm.

Modality
CT/CTA
Anatomy
Brain
Decision
2026-01-27
FDA-cleared K252482

CogNet AI-MT+

Medcognetics, Inc.

Prioritizes suspicious screening DBT examinations for MQSA interpreting physicians; every examination remains subject to full physician review.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2025-12-11
FDA-cleared K252366

a2z-Unified-Triage

A2z Radiology Ai, Inc.

Adult abdominal/pelvic CT triage for acute cholecystitis, acute pancreatitis, unruptured AAA, acute diverticulitis, free air, hydronephrosis, and small-bowel obstruction.

Modality
CT/CTA
Anatomy
Abdomen and Pelvis
Decision
2025-11-24
FDA-cleared K251610

qER-CTA (v1.0)

Qure.ai Technologies

Parallel notification of suspected anterior-circulation large vessel occlusion on acute head CTA for specialist review; notification only, not diagnosis.

Modality
CT/CTA
Anatomy
Brain anterior circulation: internal carotid artery and M1 segment of the middle cerebral artery
Decision
2025-09-08
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 K251406

BriefCase-Triage

Aidoc Medical, Ltd.

Parallel triage notification of suspected aortic dissection on contrast CT chest/abdomen; compressed previews are not diagnostic.

Modality
CT/CTA
Anatomy
Chest and abdomen; suspected aortic dissection
Decision
2025-05-30
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 K243145

syngo.CT LVO Detection

Siemens Medical Solutions USA, Inc.

AI-assisted acute-care triage and notification of suspected large-vessel occlusion on contrast-enhanced head CTA to prioritize review; not diagnosis.

Modality
CT/CTA
Anatomy
Brain/head vasculature, specifically the ICA, M1, and M2 segments
Decision
2025-04-10
FDA-cleared K243808

Rayvolve PTX-PE

AZmed

Passive study-level worklist triage for suspected pneumothorax and/or pleural effusion on adult PA or AP chest X-rays; it is not a proactive specialist alert.

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2025-03-21
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 K250248

BriefCase-Triage

Aidoc Medical, Ltd.

Parallel-workflow triage and notification of suspected incidental pulmonary embolism on contrast-enhanced images that include the lungs.

Modality
CT/CTA
Anatomy
Chest and lungs
Decision
2025-02-14
FDA-cleared K242467

IQ-UIP

Imbio, Inc.

Passive referral notification of chest-CT findings suggestive of radiological usual interstitial pneumonia to specialists associated with interstitial-lung-disease centers; not...

Modality
CT/CTA
Anatomy
Chest/lungs, specifically radiological usual interstitial pneumonia pattern
Decision
2024-12-19
FDA-cleared K243548

BriefCase-Triage

Aidoc Medical, Ltd.

Workflow triage and notification of suspect cases with three or more acute rib-fracture (RibFx) pathologies in adults or transitional adolescents aged 18 and older.

Modality
CT/CTA
Anatomy
Ribs
Decision
2024-12-11
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 K240942

CINA-CSpine

Avicenna.AI

Assist hospital networks and appropriately trained physician specialists by flagging suspected acute cervical-spine fractures on cervical-spine CT for triage and prioritization;...

Modality
CT/CTA
Anatomy
Cervical spine; acute cervical-spine fractures including non-displaced lines and displaced fragments
Decision
2024-09-12
FDA-cleared K241280

Constellation (CON-001)

Q Bio, Inc.

Constellation is intended for non-invasive labeling and calculation of quantitative measurements for anatomical regions using whole-body DICOM MR images gathered on a GE MR450W....

Modality
MRI
Anatomy
Whole body including lower-limb muscles, visceral and subcutaneous adipose tissue, kidneys, liver, spleen, lungs, and brain structures
Decision
2024-09-12
FDA-cleared K240612

CINA-VCF

Avicenna.AI

Parallel worklist triage for suspected vertebral compression fractures in patients aged 50 years and over within the standard-of-care bone-health setting; not a diagnostic device

Modality
CT/CTA
Anatomy
Thoracic and lumbar vertebrae T1-L5 within chest and/or abdomen CT
Decision
2024-05-31
FDA-cleared K233108

VinDr-Mammo

VinBigData Joint Stock Company

The VinDr-Mammo is a passive notification for prioritization-only, a parallel- workflow software tool used by MQSA qualified interpreting physicians to prioritize patients with...

Modality
Mammography/DBT
Anatomy
Breast
Decision
2024-05-23
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 K232410

SmartChest

Milvue

Passive worklist prioritization for suspected pleural effusion and/or pneumothorax on frontal PA or AP chest radiographs in transitional adolescents aged 18-21 and adults aged 22...

Modality
X-ray/Radiography
Anatomy
Chest/lung
Decision
2024-05-10
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 K233968

CINA-iPE

Avicenna.AI

Worklist triage and notification for suspected incidental pulmonary embolism on contrast-enhanced CT acquired for another indication; not a diagnostic device

Modality
CT/CTA
Anatomy
Lung and pulmonary arterial segments containing incidental pulmonary embolism; subsegmental arteries are out of scope
Decision
2024-03-13
FDA-cleared K231871

Radify Triage

Envisionit DeepAI Ltd

Passively triage adult frontal chest X-rays for suspected pleural effusion and/or pneumothorax by providing case-level PACS worklist output; not a standalone clinical-decision...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2024-01-17
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 K223754

BraveCX

Bering Ltd

Passive worklist triage for suspected pleural effusion and/or pneumothorax in adult chest radiographs

Modality
X-ray/Radiography
Anatomy
Chest/lung, targeting pleural effusion and pneumothorax
Decision
2023-11-09
FDA-cleared K232751

BriefCase-Triage

Aidoc Medical, Ltd.

Case-level triage and notification of suspected central pulmonary embolism on CTPA in adults or transitional adolescents aged 18 years and older, in parallel with standard-of-care...

Modality
CT/CTA
Anatomy
Chest and central pulmonary arteries
Decision
2023-10-30
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 K231837

Brainomix 360 Triage LVO

Brainomix Limited

Notification-only, parallel triage of acute-setting brain CTA studies for suspected large-vessel occlusion (LVO), communicating cases to a neurovascular specialist for review; not...

Modality
CT/CTA
Anatomy
Brain/head vasculature, specifically terminal ICA and MCA-M1
Decision
2023-09-28
FDA-cleared K231384

Annalise Enterprise CTB Triage Trauma

Annalise-AI Pty Ltd.

Study-level triage and prioritization notification for suspected mass effect on non-contrast brain CT in patients aged 22 years and older; not a stand-alone decision or rule-out...

Modality
CT/CTA
Anatomy
Brain/head
Decision
2023-09-22
FDA-cleared K231767

Annalise Enterprise CTB Triage Trauma

Annalise-AI Pty Ltd

Aid triage and prioritization of adult patients aged 22 years or older with non-contrast brain CT studies containing features suggestive of vasogenic edema by providing...

Modality
CT/CTA
Anatomy
Brain
Decision
2023-09-22
FDA-cleared K230899

qXR-PTX-PE

Qure.ai Technologies

Analyze adult frontal chest X-ray images for suspected pleural effusion and/or pneumothorax and provide case-level passive output for PACS/workstation worklist prioritization or...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2023-08-22
FDA-cleared K231094

Annalise Enterprise CTB Triage-OH

Annalise-AI Pty Ltd

Aid triage and prioritization of adult patients aged 22 years or older with non-contrast brain CT studies containing features suggestive of obstructive hydrocephalus by providing...

Modality
CT/CTA
Anatomy
Brain
Decision
2023-08-15
FDA-cleared K223443

Viz AAA

Viz. ai, Inc.

Viz AAA is a radiological computer-assisted triage and notification software device for analysis of CTA images of the abdomen. The device is intended to assist hospital networks...

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2023-03-17
FDA-cleared K230020

BriefCase

Aidoc Medical, Ltd.

Chest CT (with or without contrast) triage and notification for suspected three or more acute rib fractures in adults or transitional adolescents age 18 or older; notifications...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2023-02-01
FDA-cleared K222692

BriefCase

Aidoc Medical, Ltd.

Chest and abdominal CT triage and notification for suspected vertebral compression fractures in the standard-of-care bone-health workflow; notifications are non-diagnostic and...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2022-12-05
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 K221330

BriefCase

Aidoc Medical, Ltd.

BriefCase analyzes frontal chest X-rays in adults or transitional adolescents at least 18 years old to triage suspected vertically malpositioned endotracheal tubes relative to the...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2022-11-18
FDA-cleared K223042

Viz LVO ContaCT

Viz.ai, Inc.

Notification-only parallel workflow to identify and communicate suspected large vessel occlusion on acute brain CTA to a neurovascular specialist; identification is not for...

Modality
CT/CTA
Anatomy
Brain, specifically the terminal internal carotid artery and MCA-M1 vessels
Decision
2022-10-21
FDA-cleared K220709

BriefCase

Aidoc Medical, Ltd.

Notification-only triage of adult head CTA for suspected complete large-vessel and medium-vessel occlusions; compressed previews are informational and the full study remains...

Modality
CT/CTA
Anatomy
Brain/Cerebrovascular
Decision
2022-10-07
FDA-cleared K220080

CogNet QmTRIAGE

MedCognetics, Inc.

The MedCognetics (CogNet) QmTRIAGE TM software is a passive notification for prioritization-only, parallel-workflow software tool used by MQSA qualified interpreting physicians to...

Modality
Mammography/DBT
Anatomy
Breast
Decision
2022-09-29
FDA-cleared K222329

BriefCase

Aidoc Medical, Ltd.

BriefCase is a radiological computer-aided triage and notification software indicated for use in the analysis of CT exams with contrast (CTA and CT with contrast) that include the...

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2022-09-28
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 K221241

DrAid for Radiology v1

VinBrain Joint Stock Company

The DrAidTM for Radiology v1 is a radiological computer-assisted triage & notification software product designed to aid the clinical assessment of adult Chest X-Ray cases with...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2022-09-01
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 K221314

BriefCase

Aidoc Medical, Ltd.

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of head CTA images in adults or transitional adolescents aged 18 and...

Modality
CT/CTA
Anatomy
Brain/Cerebrovascular
Decision
2022-06-03
FDA-cleared K213886

BriefCase

Aidoc Medical, Ltd.

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of contrast-enhanced chest CTs (not dedicated CTPA protocol) in...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2022-04-26
FDA-cleared K213721

BriefCase

Aidoc Medical, Ltd.

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of head CT Angio (CTA) images. The device is intended to assist...

Modality
CT/CTA
Anatomy
Brain
Decision
2022-03-21
FDA-cleared K214043

BriefCase

Aidoc Medical, Ltd.

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of Chest X-Ray images in adults or transitional adolescents aged 18...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2022-03-14
FDA-cleared K213566

ClearRead Xray Pneumothorax

Riverain Technologies, Inc.

ClearRead Xray Pneumothorax is a notification-only triage workflow tool for use by trained professionals to help prioritize chest X-rays. The device operates in parallel to and...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2022-03-10
FDA-cleared K213319

Viz ANEURYSM, Viz ANX

Viz.ai, Inc.

Viz ANEURYSM (Viz ANX) is a radiological computer-assisted triage and notification software device for analysis of CT images of the head. The device is intended to assist hospital...

Modality
CT/CTA
Anatomy
Head
Decision
2022-02-18
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 K211803

HealthPPT

Zebra Medical Vision Ltd.

The HealthPPT device is a software workflow tool designed to aid the clinical assessment of adult frontal Chest X-Raycases with features suggestive of pneumoperitoneum in the...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2021-12-15
FDA-cleared K211733

Lunit INSIGHT CXR Triage

Lunit Inc.

Lunit INSIGHT CXR Triage is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pre-specified suspected...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2021-11-10
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 K210237

CINA CHEST

Avicenna.AI

Radiological computer-aided triage and notification for chest CTA suspected pulmonary embolism and chest or thoraco-abdominal CTA suspected aortic dissection, assisting hospital...

Modality
CT/CTA
Anatomy
Chest and thoraco-abdominal aorta
Decision
2021-05-19
FDA-cleared K203517

Saige-Q

DeepHealth, Inc.

Saige-Q is a software workflow tool designed to aid radiologists in prioritizing exams within the standard-of-care image worklist for compatible FFDM and DBT screening mammograms....

Modality
Mammography/DBT
Anatomy
Breast
Decision
2021-04-16
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 K193271

uAI EasyTriage-Rib

Shanghai United Imaging Intelligence Co., Ltd.

uAI EasyTriage-Rib is a radiological computer-assisted triage and notification software device for analysis of CT chest images. The device is intended to assist hospital networks...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2021-01-15
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 K201020

BriefCase

Aidoc Medical, Ltd.

BriefCase analyzes contrast-enhanced chest CT for suspected pulmonary embolism and notifies or prioritizes the study in the labeled hospital or cloud worklist workflow; the output...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2020-08-26
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 K200905

HealthMammo

Zebra Medical Vision Ltd.

The Zebra HealthMammo is a passive notification for prioritization-only, parallel-workflow software tool used by MQSA-qualified interpreting physicians to prioritize patients with...

Modality
Mammography/DBT
Anatomy
Breast
Decision
2020-07-16
FDA-cleared K200941

Rapid LVO

iSchemaView Inc.

Notification-only triage of adult head CTA for suspected large-vessel occlusion; results do not replace diagnostic interpretation.

Modality
CT/CTA
Anatomy
Brain
Decision
2020-07-09
FDA-cleared K193298

BriefCase

Aidoc Medical, Ltd.

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of abdominal CT images. The device is intended to assist hospital...

Modality
CT/CTA
Anatomy
Abdomen
Decision
2020-06-19
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 K192901

HealthVCF

Zebra Medical Vision Ltd.

Passive, prioritization-only, parallel-workflow notification for clinicians in bone-health settings to prioritize chest and abdominal CT cases suggestive of at least one vertebral...

Modality
CT/CTA
Anatomy
Vertebral bodies and spine as seen on chest and abdominal CT; suspected vertebral compression fractures
Decision
2020-05-12
FDA-cleared K193351

NinesAI

Nines, Inc.

NinesAI is a parallel workflow tool indicated for use by hospital networks and trained clinicians to identify images of specific patients to a radiologist, independent of standard...

Modality
CT/CTA
Anatomy
Brain
Decision
2020-04-21
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 K193300

AIMI-Triage CXR PTX

RADLogics, Inc.

The AIMI-Triage CXR PTX Application is a notification-only triage workflow toll for use by hospital networks and clinics to identify and help prioritize chest X-rays acquired in...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2020-04-08
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 K191556

Red Dot

Behold.AI Technologies Limited

The red dot software platform is a software workflow tool designed to aid the clinical assessment of adult chest X-Ray cases with features suggestive of Pneumothorax in the...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2020-02-28
FDA-cleared K192383

BriefCase

Aidoc Medical, Ltd.

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of head CTA images. The device is intended to assist hospital...

Modality
CT/CTA
Anatomy
Brain/Cerebrovascular
Decision
2019-12-20
FDA-cleared K183182

Critical Care Suite

GE Medical Systems, LLC.

Computer aided triage and notification device that analyzes frontal chest x-ray images for the presence of prespecified critical findings (pneumothorax). Critical Care Suite...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2019-08-12
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 K190896

BriefCase

Aidoc Medical, Ltd.

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of cervical spine on CT images. The device is intended to assist...

Modality
CT/CTA
Anatomy
Spine
Decision
2019-05-31
FDA-cleared K183285

cmTriage

CureMetrix, Inc

Passive, prioritization-only notification of 2D FFDM screening mammograms with at least one suspicious finding at the exam level; not diagnostic.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2019-03-08
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-authorized DEN170073

ContaCT

Viz.Al, Inc.

ContaCT 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
2018-02-13
FDA-cleared K163138

Clarius Ultrasound System

Clarius Mobile Health Corp.

The Clarius Ultrasound System is a software-based ultrasound imaging system and accessories for point-of-care imaging of medical conditions, including emergency triage for trauma,...

Modality
Ultrasound
Anatomy
General human-body anatomy; listed point-of-care ultrasound applications
Decision
2016-11-30