Circle Cardiovascular Imaging, Inc. radiology AI products

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FDA-cleared K251027

cvi42 Coronary Plaque Software Application

Circle Cardiovascular Imaging, Inc.

Authorized purpose: cvi42 Coronary Plaque supports qualified professionals with viewing, post-processing, and qualitative and quantitative evaluation of adult cardiac CT DICOM images to assess the presence and extent of coronary plaques and stenoses in CCTA for CAD or suspected CAD.

Modality: CT/CTA
Anatomy: Heart/Cardiovascular
Decision: 2025-10-27

FDA-cleared K250221

StrokeSENS ASPECTS Software Application

Circle Cardiovascular Imaging Inc.

Authorized purpose: ASPECTS scoring and highlighted-region/voxel visualization to assist assessment of ischemic brain injury in known MCA/ICA occlusion within 12 hours from last known well.

Modality: CT/CTA
Anatomy: Brain ASPECTS regions in patients with known MCA or ICA occlusion
Decision: 2025-07-01

CT/CTA workflow

FDA-cleared K242781

cvi42 Software Application

Circle Cardiovascular Imaging Inc.

Authorized purpose: View, post-process, and qualitatively and quantitatively evaluate cardiovascular MR and CT images in DICOM format to obtain diagnostic information as part of a comprehensive diagnostic decision-making process.

Modality: CT/CTA; MRI
Anatomy: Cardiovascular system; heart, coronary and adjacent vessels, and cardiac valves
Decision: 2024-10-15

Cardiac imaging Quantification and segmentation

FDA-cleared K222593

TruPlan Computed Tomography (CT) Imaging Software

Circle Cardiovascular Imaging, Inc.

Authorized purpose: Visualization, measurement, pre-procedural planning and sizing, and post-procedural evaluation for left atrial appendage closure (LAAC); the software is a planning and assessment aid and not a diagnostic replacement.

Modality: CT/CTA
Anatomy: Left atrial appendage and adjacent cardiac and extracardiac cardiovascular structures
Decision: 2023-01-18

Cardiac imaging Quantification and segmentation

FDA-cleared K213998

cvi42 Auto Imaging Software Application

Circle Cardiovascular Imaging Inc

Authorized purpose: Viewing, post-processing, qualitative and quantitative evaluation, cardiac measurements, calcium scoring, and evaluation of physician-identified vascular lesions in cardiovascular MR/CT images.

Modality: CT/CTA; MRI
Anatomy: Heart and adjacent cardiovascular vessels
Decision: 2022-07-28

Cardiac imaging Quantification and segmentation

FDA-cleared K202212

TruPlan

Circle Cardiovascular Imaging Inc.

Authorized purpose: TruPlan provides CT image processing, visualization, measurements, and cardiac procedure-planning workflow support for the labeled use; exact procedure scope and outputs are release-specific.

Modality: CT/CTA
Anatomy: Heart/Cardiovascular
Decision: 2021-02-19

Cardiac imaging Quantification and segmentation

FDA-cleared K141480

CVI42

CIRCLE CARDIOVASCULAR IMAGING INC

Authorized purpose: cvi42 analyzes cardiovascular CT and MRI with MPR, MIP, volume rendering, centerlines, lumen and stenosis measurements, and reporting for qualified professionals.

Modality: Radiological images; modality varies or is not specified in FDA list
Anatomy: Heart/Cardiovascular
Decision: 2014-08-22

Cardiac imaging Quantification and segmentation