FDA-cleared K251203

AVIEW Lung Nodule CAD

Coreline Soft Co.,Ltd

Adjunctive alert and second-reader information for radiologists interpreting non-contrast chest CT in asymptomatic populations; the cleared nodule range is 3-20 mm.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2025-12-03
FDA-cleared K250766

LungQ 4

Thirona BV

Quantitative support for thoracic CT interpretation and treatment planning, including emphysema burden, airway/lung segmentation, endobronchial valve assessment and estimated...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2025-10-02
FDA-cleared K241891

ScreenDx

Imvaria, Inc

ScreenDx provides adjunctive positive/negative assessment of interstitial lung findings on DICOM lung CT in patients older than 22 years to support referral for clinical...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2025-01-10
FDA-authorized DEN220040

Fibresolve

Imvaria, Inc

Fibresolve is a software-only device that receives and analyzes lung computed tomography (CT) imaging data in order to provide a diagnostic subtype classification in suspected...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2024-01-12
FDA-cleared K232412

LungQ v3.0.0

Thirona BV

The Thirona LungQ software provides reproducible CT values for pulmonary tissue which is essential for providing quantitative support for diagnosis and follow up examination. The...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2024-01-08
FDA-cleared K221592

AVIEW Lung Nodule CAD

Coreline Soft Co.,Ltd.

AVIEW Lung Nodule CAD is a Computer-Aided Detection (CAD) software designed to assist radiologists in the detection of pulmonary nodules (with diameter 3-20 mm) during the review...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2023-02-24
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 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 K203783

ClariPulmo

ClariPi Inc.

ClariPulmo is a non-invasive image analysis software for use with CT images which is intended to support the quantification of lung CT images. The software is designed to support...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2022-04-06
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 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 K200990

VIDAvision

VIDA Diagnostics Inc.

The VIDA|vision software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations....

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2020-08-07
FDA-cleared K191550

Broncholab

Fluidda Inc.

Broncholab provides physicians with reproducible CT values for pulmonary tissue for providing quantitative support for diagnosis and follow-up examination. Broncholab can be used...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2020-03-04
FDA-cleared K183593

Lung Vision System

Body Vision Medical Ltd.

The LungVision System is intended to enable users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with fluoroscopic live X-ray...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2019-04-18
FDA-cleared K120161

ALPHAPOINT IMAGING SOFTWARE

RADLOGICS, INC.

The AlphaPoint software is a device that allows review, analysis, and interchange of CT chest images. The software provides segmentation and Hounsfield numerical analysis values...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2012-04-13