FDA-cleared K161201
ClearRead CT
RIVERAIN TECHNOLOGIES, LLC
ClearRead CT provides adjunctive information and is not intended to be used without the o.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2016-09-09
Use case
Chest CT radiology AI tools
A buyer-oriented shortlist for chest ct. Confirm exact intended use and local validation needs before any pilot or procurement decision.
FDA-cleared K163622
Lung Vision
BODY VISION MEDICAL LTD.
cations for Use LungVision System Indications for Use: The LungVision System is intended to enable users to segment previously acquired 3D CT datasets and overlay and register...
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2017-05-11
FDA-cleared K173821
LungQ Software
Thirona Corporation
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2018-06-05
FDA-cleared K183271
AI-Rad Companion (Pulmonary)
Siemens Medical Solutions USA, Inc.
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2019-07-26
FDA-cleared K193216
syngo.CT Lung CAD
Siemens Medical Solutions, Inc
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2020-03-09
FDA-cleared K192880
InferRead Lung CT.AI
Beijing Infervision Technology Co.,Ltd.
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2020-07-02
FDA-cleared K203258
syngo.CT Lung CAD
Siemens Healthcare GmbH
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2021-03-31
FDA-cleared K210237
CINA CHEST
Avicenna.AI
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2021-05-19
FDA-cleared K213096
Al-Rad Companion (Pulmonary)
Siemens Medical Solutions USA, Inc.
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2021-12-06
FDA-cleared K213713
AI-Rad Companion (Pulmonary)
Siemens Healthcare GmBh
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2022-08-11
FDA-cleared K221592
AVIEW Lung Nodule CAD
Coreline Soft Co.,Ltd.
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2023-02-24
FDA-cleared K231157
syngo.CT Lung CAD (Version VD30)
Siemens Healthcare GmbH
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2023-07-19
FDA-cleared K232412
LungQ v3.0.0
Thirona BV
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2024-01-08
FDA-cleared K233753
AI-Rad Companion (Pulmonary)
Siemens Healthcare GmbH
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2024-03-21
FDA-cleared K240943
LungVision
BodyVision Medical Ltd.
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2024-10-01
FDA-cleared K241200
SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option
Arineta Ltd.
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2025-01-13
FDA-cleared K242919
V5med Lung AI
V5med Inc.
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2025-03-27
FDA-cleared K250650
SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
Arineta Ltd.
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2025-04-15
FDA-cleared K243239
Lung AI (LAI001)
Exo Inc
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2025-04-24
FDA-cleared K240554
InferRead Lung CT.AI
Infervision Medical Technology Co., Ltd.
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2025-05-16
FDA-cleared K250766
LungQ 4
Thirona BV
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2025-10-02
FDA-cleared K251203
AVIEW Lung Nodule CAD
Coreline Soft Co.,Ltd
Image analysis/processing for Chest/Lung using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Chest/Lung
- Decision
- 2025-12-03