Acute triage and notification radiology AI tools

FDA-cleared K260729

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

GuideAI Health

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Vascular
Decision: 2026-06-18

Detection and CADe Acute triage and notification

FDA-cleared K261317

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2026-05-14

Detection and CADe Acute triage and notification

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

Breast imaging Acute triage and notification

FDA-cleared K253163

EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)

Ever Fortune.Ai, Co., Ltd.

Triage notification of suspected appendicitis on contrast-enhanced abdominal CT

Modality: CT/CTA
Anatomy: Abdomen
Decision: 2026-04-22

Acute triage and notification

FDA-cleared K252421

JLK-NCCT

JLK, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2026-03-24

Detection and CADe Acute triage and notification

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

Acute triage and notification

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

MSK and bone Acute triage and notification

FDA-cleared K251195

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2026-01-27

Detection and CADe Acute triage and notification

FDA-cleared K252970

BriefCase-Triage: CARE Multi-triage CT Body

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2026-01-07

Detection and CADe Acute triage and notification

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

Breast imaging Acute triage and notification

FDA-cleared K250694

Scaida BrainCT-ICH (v1.0)

Mlhealth 360

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2025-11-25

Detection and CADe Acute triage and notification

FDA-cleared K252366

a2z-Unified-Triage

A2z Radiology Ai, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-11-24

Detection and CADe Acute triage and notification

FDA-cleared K253265

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-11-06

Detection and CADe Acute triage and notification

FDA-cleared K251610

qER-CTA (v1.0)

Qure.ai Technologies

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-09-08

Detection and CADe Acute triage and notification

FDA-cleared K251533

Rapid Obstructive Hydrocephalus, Rapid OH

iSchemaView Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Head/Neck
Decision: 2025-09-04

Detection and CADe Acute triage and notification

FDA-cleared K251983

Brainomix 360 Triage Stroke

Brainomix Limited

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2025-08-26

Detection and CADe Acute triage and notification

FDA-cleared K251590

Methinks CTA Stroke

Methinks Software S.L.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2025-08-20

Detection and CADe Acute triage and notification

FDA-cleared K251151

Rapid CTA 360

iSchemaView

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-07-16

Detection and CADe Acute triage and notification

FDA-cleared K250685

Methinks NCCT Stroke

Methinks Software S.L.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2025-06-16

Detection and CADe Acute triage and notification

FDA-cleared K251406

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-05-30

Detection and CADe Acute triage and notification

FDA-cleared K250831

Annalise Enterprise

Annalise-AI

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2025-04-23

Detection and CADe Acute triage and notification

FDA-cleared K243145

syngo.CT LVO Detection

Siemens Medical Solutions USA, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2025-04-10

Detection and CADe Acute triage and notification

FDA-cleared K242919

V5med Lung AI

V5med Inc.

V5med Lung AI provides concurrent-read adjunctive notification of suspected pulmonary nodules on chest CT; it does not replace radiologist judgment, diagnostic processes, or...

Modality: CT/CTA
Anatomy: Chest/Lung
Decision: 2025-03-27

Lung nodule detection Acute triage and notification Chest CT

FDA-cleared K243808

Rayvolve PTX-PE

AZmed

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2025-03-21

Detection and CADe Acute triage and notification

FDA-cleared K243611

JLK-SDH

JLK, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-03-03

Detection and CADe Acute triage and notification

FDA-cleared K242821

EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)

Ever Fortune.AI, Co., Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2025-02-20

Detection and CADe Acute triage and notification

FDA-cleared K250248

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-02-14

Detection and CADe Acute triage and notification

FDA-cleared K243363

JLK-ICH

JLK, Inc.

Notification-only triage of suspected intracranial hemorrhage on non-contrast head CT

Modality: CT/CTA
Anatomy: Brain
Decision: 2025-01-03

Stroke and ICH triage Acute triage and notification

FDA-cleared K243548

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-12-11

Detection and CADe Acute triage and notification

FDA-cleared K241923

EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)

Ever Fortune.AI, Co., Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2024-12-06

Detection and CADe Acute triage and notification

FDA-cleared K241439

VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage

Vuno Inc.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2024-11-15

Detection and CADe Acute triage and notification

FDA-cleared K241719

NeuroICH

Neurocareai Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2024-11-07

Detection and CADe Acute triage and notification

FDA-cleared K242837

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-10-18

Detection and CADe Acute triage and notification

FDA-cleared K241480

JBS-LVO

JLK, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2024-09-27

Detection and CADe Acute triage and notification

FDA-cleared K242292

uAI Easy Triage ICH

Shanghai United Imaging Intelligence Co., Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2024-09-24

Detection and CADe Acute triage and notification

FDA-cleared K240942

CINA-CSpine

Avicenna.AI

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Spine
Decision: 2024-09-12

MSK and bone Detection and CADe Acute triage and notification

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

Oncology quantification Quantification and segmentation Acute triage and notification

FDA-cleared K241727

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-07-12

Detection and CADe Acute triage and notification

FDA-cleared K240353

Hyper Insight - ICH

SK Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2024-07-01

Detection and CADe Acute triage and notification

FDA-cleared K240612

CINA-VCF

Avicenna.AI

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-05-31

Detection and CADe Acute triage and notification

FDA-cleared K233108

VinDr-Mammo

VinBigData Joint Stock Company

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

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

Breast imaging Detection and CADe Acute triage and notification

FDA-cleared K233247

Heuron ICH

Heuron Co., Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2024-05-15

Detection and CADe Acute triage and notification

FDA-cleared K232410

SmartChest

Milvue

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2024-05-10

Detection and CADe Acute triage and notification

FDA-cleared K240291

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

Ever Fortune.AI, Co., Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Cardiovascular
Decision: 2024-04-08

Detection and CADe Acute triage and notification

FDA-cleared K232431

syngo.CT Brain Hemorrhage

Siemens Medical Solutions USA, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2024-03-22

Detection and CADe Acute triage and notification

FDA-cleared K233968

CINA-iPE

Avicenna.AI

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-03-13

Detection and CADe Acute triage and notification

FDA-cleared K231871

Radify Triage

Envisionit DeepAI Ltd

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2024-01-17

Detection and CADe Acute triage and notification

FDA-cleared K232496

Brainomix 360 Triage Stroke

Brainomix Limited

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2023-11-21

Detection and CADe Acute triage and notification

FDA-cleared K223754

BraveCX

Bering Ltd

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2023-11-09

Detection and CADe Acute triage and notification

FDA-cleared K232751

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-10-30

Detection and CADe Acute triage and notification

FDA-cleared K232436

Rapid SDH

iSchemaView, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-10-25

Detection and CADe Acute triage and notification

FDA-cleared K231025

EFAI NeuroSuite CT ICH Assessment System

Ever Fortune.AI Co., Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2023-10-04

Detection and CADe Acute triage and notification

FDA-cleared K231837

Brainomix 360 Triage LVO

Brainomix Limited

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2023-09-28

Detection and CADe Acute triage and notification

FDA-cleared K231384

Annalise Enterprise CTB Triage Trauma

Annalise-AI Pty Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-09-22

Detection and CADe Acute triage and notification

FDA-cleared K231767

Annalise Enterprise CTB Triage Trauma

Annalise-AI Pty Ltd

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-09-22

Detection and CADe Acute triage and notification

FDA-cleared K230899

qXR-PTX-PE

Qure.ai Technologies

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2023-08-22

Detection and CADe Acute triage and notification

FDA-cleared K231094

Annalise Enterprise CTB Triage-OH

Annalise-AI Pty Ltd

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-08-15

Detection and CADe Acute triage and notification

FDA-cleared K230074

Rapid Aneurysm Triage and Notification

iSchemaView Inc.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: CT/CTA
Anatomy: Brain
Decision: 2023-07-27

Detection and CADe Acute triage and notification

FDA-cleared K231195

Brainomix 360 Triage ICH

Brainomix Limited

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2023-07-27

Detection and CADe Acute triage and notification

FDA-cleared K223240

Annalise Enterprise CTB Triage Trauma

Annalise-AI Pty Ltd

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-04-03

Detection and CADe Acute triage and notification

FDA-cleared K222179

Annalise Enterprise CXR Triage Trauma

Annalise-AI Pty Ltd

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2023-03-28

Detection and CADe Acute triage and notification

FDA-cleared K222268

Annalise Enterprise CXR Triage Trauma

Annalise-AI Pty Ltd

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2023-03-28

Detection and CADe Acute triage and notification

FDA-cleared K223443

Viz AAA

Viz. ai, Inc.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-03-17

Detection and CADe Acute triage and notification

FDA-cleared K222884

Rapid NCCT Stroke

iSchemaView, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2023-03-02

Detection and CADe Acute triage and notification

FDA-cleared K230020

BriefCase

Aidoc Medical, Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-02-01

Detection and CADe Acute triage and notification

FDA-cleared K221868

QOCA image Smart CXR Image Processing System

Quanta Computer Inc.

QOCA image Smart CXR analyzes adult chest X-ray images and flags cases with suspected pneumothorax to support prioritization for radiologist review.

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2023-01-27

Acute triage and notification

FDA-cleared K222692

BriefCase

Aidoc Medical, Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-12-05

Detection and CADe Acute triage and notification

FDA-cleared K221716

CINA

AVICENNA.AI

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-11-22

Detection and CADe Acute triage and notification

FDA-cleared K221330

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2022-11-18

Detection and CADe Acute triage and notification

FDA-cleared K221552

EFAI ChestSuite XR Pneumothorax Assessment System

Ever Fortune AI Co., Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2022-11-08

Detection and CADe Acute triage and notification

FDA-cleared K223042

Viz LVO ContaCT

Viz.ai, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2022-10-21

Detection and CADe Acute triage and notification

FDA-cleared K220709

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-10-07

Detection and CADe Acute triage and notification

FDA-cleared K220080

CogNet QmTRIAGE

MedCognetics, Inc.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2022-09-29

Breast imaging Detection and CADe Acute triage and notification

FDA-cleared K222329

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-09-28

Detection and CADe Acute triage and notification

FDA-cleared K221456

Rapid ICH

iSchemaView Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2022-09-12

Detection and CADe Acute triage and notification

FDA-cleared K222076

EFAI ChestSuite XR Pleural Effusion Assessment System

Ever Fortune.AI Co., Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2022-09-08

Detection and CADe Acute triage and notification

FDA-cleared K221241

DrAid for Radiology v1

VinBrain Joint Stock Company

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2022-09-01

Detection and CADe Acute triage and notification

FDA-cleared K222277

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-08-26

Detection and CADe Acute triage and notification

FDA-cleared K220439

Viz SDH

Viz.ai, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-07-25

Detection and CADe Acute triage and notification

FDA-cleared K221314

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-06-03

Detection and CADe Acute triage and notification

FDA-cleared K221248

Rapid LVO

iSchemaView Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2022-05-31

Detection and CADe Acute triage and notification

FDA-cleared K220499

Rapid PE Triage and Notification (PETN)

iSchemaView Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-05-17

Detection and CADe Acute triage and notification

FDA-cleared K221240

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-05-17

Detection and CADe Acute triage and notification

FDA-cleared K213886

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-04-26

Detection and CADe Acute triage and notification

FDA-cleared K213721

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-03-21

Detection and CADe Acute triage and notification

FDA-cleared K214043

BriefCase

Aidoc Medical, Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2022-03-14

Detection and CADe Acute triage and notification

FDA-cleared K213566

ClearRead Xray Pneumothorax

Riverain Technologies, Inc.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2022-03-10

Detection and CADe Acute triage and notification

FDA-cleared K213941

Annalise Enterprise CXR Triage Pneumothorax

Annalise-AI

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2022-02-24

Detection and CADe Acute triage and notification

FDA-cleared K213319

Viz ANEURYSM, Viz ANX

Viz.ai, Inc.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: CT/CTA
Anatomy: Brain
Decision: 2022-02-18

Detection and CADe Acute triage and notification

FDA-cleared K203260

syngo.CT Brain Hemorrhage

Siemens Medical Solutions USA, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2022-01-28

Detection and CADe Acute triage and notification

FDA-cleared K211803

HealthPPT

Zebra Medical Vision Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2021-12-15

Detection and CADe Acute triage and notification

FDA-cleared K211733

Lunit INSIGHT CXR Triage

Lunit Inc.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

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

Detection and CADe Acute triage and notification

FDA-cleared K212261

StrokeSENS LVO

Circle Neurovascular Imaging, Inc

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2021-10-14

Detection and CADe Acute triage and notification

FDA-cleared K211179

InferRead CT Stroke.AI

Infervision Medical Technology Co., Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2021-08-12

Detection and CADe Acute triage and notification

FDA-cleared K211788

HALO

Nico.Lab B.V.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2021-07-08

Detection and CADe Acute triage and notification

FDA-cleared K210237

CINA CHEST

Avicenna.AI

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Chest/Lung
Decision: 2021-05-19

Detection and CADe Acute triage and notification Chest CT

FDA-cleared K203517

Saige-Q

DeepHealth, Inc.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2021-04-16

Breast imaging Detection and CADe Acute triage and notification

FDA-cleared K202992

BriefCase, RIB Fractures Triage (RibFx)

Aidoc Medical, Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: CT/CTA
Anatomy: Bone
Decision: 2021-04-14

MSK and bone Detection and CADe Acute triage and notification

FDA-cleared K210209

Viz ICH

Viz.ai, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2021-03-23

Detection and CADe Acute triage and notification

FDA-cleared K193271

uAI EasyTriage-Rib

Shanghai United Imaging Intelligence Co., Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: CT/CTA
Anatomy: N/A
Decision: 2021-01-15

Detection and CADe Acute triage and notification

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

Pulmonary embolism Stroke and ICH triage MSK and bone

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

Stroke and ICH triage Acute triage and notification

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

Pulmonary embolism Acute triage and notification Chest CT

FDA-cleared K201310

Accipiolx

MaxQ Al Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-08-07

Detection and CADe Acute triage and notification

FDA-cleared K200905

HealthMammo

Zebra Medical Vision Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2020-07-16

Breast imaging Detection and CADe Acute triage and notification

FDA-cleared K200941

Rapid LVO

iSchemaView Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2020-07-09

Detection and CADe Acute triage and notification

FDA-cleared K200855

CINA

AVICENNA.AI

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...

Modality: CT/CTA
Anatomy: Brain
Decision: 2020-06-24

Stroke and ICH triage Detection and CADe Acute triage and notification

FDA-cleared K193298

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-06-19

Detection and CADe Acute triage and notification

FDA-cleared K200921

qER

Qure.ai Technologies

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-06-17

Detection and CADe Acute triage and notification

FDA-cleared K192901

HealthVCF

Zebra Medical Vision Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-05-12

Detection and CADe Acute triage and notification

FDA-cleared K193351

NinesAI

Nines, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-04-21

Detection and CADe Acute triage and notification

FDA-cleared K192167

CuraRad-ICH

CuraCloud Corp.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2020-04-13

Detection and CADe Acute triage and notification

FDA-cleared K193300

AIMI-Triage CXR PTX

RADLogics, Inc.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

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

Detection and CADe Acute triage and notification

FDA-cleared K193087

Rapid ICH

iSchemaView Incorporated

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2020-03-31

Detection and CADe Acute triage and notification

FDA-cleared K193658

Viz ICH

Viz.ai, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2020-03-18

Detection and CADe Acute triage and notification

FDA-cleared K191556

Red Dot

Behold.AI Technologies Limited

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2020-02-28

Detection and CADe Acute triage and notification

FDA-cleared K192383

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-12-20

Detection and CADe Acute triage and notification

FDA-cleared K192320

HealthCXR

Zebra Medical Vision, Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2019-11-26

Detection and CADe Acute triage and notification

FDA-cleared K183182

Critical Care Suite

GE Medical Systems, LLC.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2019-08-12

Detection and CADe Acute triage and notification

FDA-cleared K182875

DeepCT

Deep01 Limited

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-07-10

Detection and CADe Acute triage and notification

FDA-cleared K190424

HealthICH

Zebra Medical Vision Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-06-13

Detection and CADe Acute triage and notification

FDA-cleared K190896

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-05-31

Detection and CADe Acute triage and notification

FDA-cleared K190362

HealthPNX

Zebra Medical Vision Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2019-05-06

Detection and CADe Acute triage and notification

FDA-cleared K190072

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-04-15

Detection and CADe Acute triage and notification

FDA-cleared K183285

cmTriage

CureMetrix, Inc

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2019-03-08

Breast imaging Detection and CADe Acute triage and notification

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

Stroke and ICH triage Acute triage and notification

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

Stroke and ICH triage Acute triage and notification

FDA-authorized DEN170073

ContaCT

Viz.Al, Inc.

Triage/notification/prioritization

Modality: CT/CTA
Anatomy: N/A
Decision: 2018-02-13

Acute triage and notification

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

Cardiac imaging Acute triage and notification Ultrasound workflow