FDA-cleared K254075

Synapse Lung Nodule AI

Fujifilm Corporation

FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2026-05-27
FDA-cleared K251769

RevealAI-Lung

Precision Medical Ventures, Inc. Dba Revealdx

FDA product code POK identifies this device class as Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer. Assist users in characterizing lesions identified on...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2026-01-30
FDA-cleared K251203

AVIEW Lung Nodule CAD

Coreline Soft Co.,Ltd

FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...

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

LungQ 4

Thirona BV

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

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-cleared K232412

LungQ v3.0.0

Thirona BV

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2024-01-08
FDA-cleared K231157

syngo.CT Lung CAD (Version VD30)

Siemens Healthcare GmbH

FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2023-07-19
FDA-cleared K221592

AVIEW Lung Nodule CAD

Coreline Soft Co.,Ltd.

FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2023-02-24
FDA-cleared K213713

AI-Rad Companion (Pulmonary)

Siemens Healthcare GmBh

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2022-08-11
FDA-cleared K213096

Al-Rad Companion (Pulmonary)

Siemens Medical Solutions USA, Inc.

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2021-12-06
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
FDA-cleared K203258

syngo.CT Lung CAD

Siemens Healthcare GmbH

FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2021-03-31
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 K192880

InferRead Lung CT.AI

Beijing Infervision Technology Co.,Ltd.

FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2020-07-02
FDA-cleared K193216

syngo.CT Lung CAD

Siemens Medical Solutions, Inc

FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2020-03-09
FDA-cleared K183593

Lung Vision System

Body Vision Medical Ltd.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2019-04-18
FDA-cleared K173821

LungQ Software

Thirona Corporation

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2018-06-05
FDA-cleared K141069

Lung Density Analysis

IMBIO LLC

FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.

Modality
CT/CTA
Anatomy
Chest/Lung
Decision
2014-09-17