Radiology AI Directory

Vendor

Coreline Soft Co.,Ltd

10 FDA-cleared listings in this directory.

Claim vendor profile
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
Chest CT
FDA-cleared K243689

AVIEW

Coreline Soft Co., Ltd.

AVIEW assists physicians with quantitative CT analysis of thoracic and cardiac datasets, including lung, lobe, airway, fissure, nodule, coronary calcium, density, measurement, and...

Modality
CT/CTA
Anatomy
Chest/lung and heart/coronary arteries
Decision
2025-03-19
Cardiac imagingQuantification and segmentation
FDA-cleared K243696

AVIEW CAC

Coreline Soft Co., Ltd.

Quantitative coronary-calcium analysis and risk stratification on existing non-contrast, non-gated chest CT studies.

Modality
CT/CTA
Anatomy
Heart and coronary arteries, specifically the right and left coronary arteries
Decision
2025-02-14
Cardiac imagingQuantification and segmentation
FDA-cleared K233211

AVIEW CAC

Coreline Soft Co., Ltd.

A VIEW CAC provides quantitative analysis of calcified plaques in the coronary arteries using non-contrast/non-gated Chest er scans. It enables the calculation of the Agatston...

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2024-03-29
Cardiac imagingQuantification and segmentation
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
Lung nodule detectionDetection and CADeChest CT
FDA-cleared K214036

AVIEW

Coreline Soft Co.,Ltd.

AVIEW provides quantitative CT analysis of pulmonary and cardiac anatomy, including lung, lobe, airway, fissure, nodule, coronary calcium, and related measurements and reports to...

Modality
CT/CTA
Anatomy
Lungs, lobes, airways, fissures, heart, coronary arteries, and pulmonary nodules
Decision
2022-12-23
Lung nodule detectionCardiac imagingQuantification and segmentation
FDA-cleared K220408

AVIEW RT ACS

Coreline Soft Co.,Ltd

AVIEW RT ACS is a medical image-management and processing system for radiation-treatment planning with deep-learning auto-segmentation evidence described in the exact FDA decision...

Modality
Radiotherapy Planning Imaging
Anatomy
Organs at risk across breast, head and neck, abdomen, and pelvis CT validation cases, including lung, heart, eyes, brain, mandible, kidneys, liver, femur, and bladder
Decision
2022-11-10
Breast imagingRadiotherapy planningCardiac imaging
FDA-cleared K201710

A View LCS

Coreline Soft Co., Ltd.

AVIEW LCS is intended for the review and analysis and reporting of thoracic CT images for the purpose of characterizing nodules in the lung in a single study, or over the time...

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2020-10-16
Cardiac imagingQuantification and segmentation
FDA-cleared K200714

AVIEW

Coreline Soft Co., Ltd

AVIEW provides CT values for pulmonary tissue from thoracic and cardiac CT datasets and supports quantitative diagnosis, follow-up evaluation, and documentation through lung,...

Modality
CT/CTA
Anatomy
Lungs, lobes, airways, pulmonary nodules, and cardiac anatomy
Decision
2020-08-26
Lung nodule detectionCardiac imagingQuantification and segmentation
FDA-cleared K193220

AVIEW LCS

Coreline Soft Co., Ltd

AVIEW LCS reviews and analyzes thoracic CT images to characterize lung nodules in a single study or over time, including nodule measurements and release-specific Lung-RADS...

Modality
CT/CTA
Anatomy
Lung
Decision
2020-05-05
Lung nodule detectionQuantification and segmentation