FDA-cleared K254075

Synapse Lung Nodule AI

Fujifilm Corporation

Concurrent-reader aid for a radiologist detecting pulmonary nodules during review of chest CT examinations in the lung cancer screening population under screening protocols.

Modality
CT/CTA
Anatomy
Chest/lungs; pulmonary nodules
Decision
2026-05-27
FDA-cleared K251769

RevealAI-Lung

Precision Medical Ventures, Inc. Dba Revealdx

Characterization and relative cancer-risk assessment of incidentally detected pulmonary nodules 6-15 mm in adults, with use as one input to follow-up and clinical decision-making...

Modality
CT/CTA
Anatomy
Pulmonary nodules in the lungs
Decision
2026-01-30
FDA-cleared K243831

Rayvolve LN

AZmed

Second-reader support for radiologists reviewing adult digital AP or PA chest radiographs, with suspected pulmonary nodules in the 6-30 mm range marked for review.

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2025-03-26
FDA-cleared K231805

qXR-LN

Qure.ai Technologies

Second-reader CADe to identify and mark suspected pulmonary nodules 6-30 mm in the incidental adult population

Modality
X-ray/Radiography
Anatomy
Chest/lung, focused on suspected pulmonary nodules
Decision
2023-12-22
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
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
FDA-cleared K201560

Auto Lung Nodule Detection

Samsung Electronics Co.,Ltd.

Identifies and marks suspected pulmonary nodules 10-30 mm on adult PA chest radiographs as a second-reader aid.

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2021-08-31
FDA-cleared K203258

syngo.CT Lung CAD

Siemens Healthcare GmbH

Adjunctive CAD assistance to alert radiologists to regions of interest that may otherwise be overlooked during chest MDCT review; concurrent first-reader or second-reader use is...

Modality
CT/CTA
Anatomy
Pulmonary nodules in the thorax, including solid and subsolid (part-solid and ground-glass) nodules.
Decision
2021-03-31
FDA-cleared K201710

A View LCS

Coreline Soft Co., Ltd.

Reviews, analyzes, and reports thoracic CT images to characterize lung nodules across single or follow-up studies.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2020-10-16
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
FDA-cleared K192880

InferRead Lung CT.AI

Beijing Infervision Technology Co.,Ltd.

Computer-assisted reading aid for radiologists detecting pulmonary nodules during review of chest CT examinations in an asymptomatic population; both lungs must be in the field of...

Modality
CT/CTA
Anatomy
Chest; pulmonary nodules in both lungs
Decision
2020-07-02
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
FDA-cleared K193216

syngo.CT Lung CAD

Siemens Medical Solutions, Inc

Adjunctive CAD assistance to alert radiologists to potentially overlooked solid pulmonary nodules during chest MDCT review; second-reader use only after the radiologist's initial...

Modality
CT/CTA
Anatomy
Solid pulmonary nodules in the thorax.
Decision
2020-03-09
FDA-cleared K173542

Arterys Oncology DL

Arterys Inc.

Oncology imaging workflow for viewing, manipulating, 3D visualizing, and comparing images and assessing/documenting morphological changes at diagnostic and therapy follow-up;...

Modality
CT/CTA; MRI
Anatomy
Oncologic lesions, with semi-automated segmentation explicitly described for lung nodules and liver lesions.
Decision
2018-01-25
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
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