Lung nodule detection radiology AI tools

FDA-cleared K251474

Median LCS (internal name) / eyonis LCS (trade name) (1.0)

Median Technologies

eyonis LCS is a concurrent-reading aid for radiologists that detects, localizes, and characterizes 4-30 mm solid and part-solid pulmonary nodules on low-dose chest CT images for...

Modality: CT/CTA
Anatomy: Chest/Lung
Decision: 2026-02-06

FDA-cleared K240554

InferRead Lung CT.AI

Infervision Medical Technology Co., Ltd.

Adjunctive pulmonary nodule detection and measurement, including temporal comparison, in chest CT screening of asymptomatic adults aged at least 55 years.

Modality: CT/CTA
Anatomy: Chest/Lung
Decision: 2025-05-16

Lung nodule detection Detection and CADe Quantification and segmentation

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 K233753

AI-Rad Companion (Pulmonary)

Siemens Healthcare GmbH

AI-Rad Companion Pulmonary is image-processing software that provides quantitative and qualitative analysis from previously acquired CT DICOM images to support radiologists and...

Modality: CT/CTA
Anatomy: Adult lungs, lung lobes, pulmonary parenchyma, and solid or sub-solid lung nodules
Decision: 2024-03-21

Lung nodule detection Detection and CADe Quantification and segmentation

FDA-cleared K223133

VisiRad XR

Imidex Inc.

VisiRad XR is a computer-aided detection device that identifies and marks regions of interest suspicious for lung nodules and masses measuring 6-60 mm on chest radiographs in...

Modality: X-ray/Radiography
Anatomy: Adult chest and pulmonary nodules or masses 6-60 mm
Decision: 2023-08-03

Lung nodule detection Detection and CADe

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 detection Cardiac imaging Quantification 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 detection Cardiac imaging Quantification 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 detection Quantification and segmentation

FDA-cleared K161201

ClearRead CT

RIVERAIN TECHNOLOGIES, LLC

ClearRead CT is a post-processing adjunct for detecting pulmonary nodules on chest CT in an asymptomatic population; it generates a secondary vessel-suppressed lung CT with CADe...

Modality: CT/CTA
Anatomy: Chest/lungs
Decision: 2016-09-09

Lung nodule detection Detection and CADe

FDA-approved P000041

RAPIDSCREEN RS-2000

RIVERAIN MEDICAL GROUP

RAPIDSCREEN RS-2000 is a PMA-authorized computer-aided detection device that identifies and marks regions of interest on digitized frontal chest radiographs associated with...

Modality: X-ray/Radiography
Anatomy: Adult chest; solitary pulmonary nodules 9-30 mm
Decision: 2001-07-12

Lung nodule detection Detection and CADe