FDA-cleared K250221

StrokeSENS ASPECTS Software Application

Circle Cardiovascular Imaging Inc.

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
FDA-cleared K242781

cvi42 Software Application

Circle Cardiovascular Imaging Inc.

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...

Modality
CT/CTA; MRI
Anatomy
Cardiovascular system; heart, coronary and adjacent vessels, and cardiac valves
Decision
2024-10-15
FDA-cleared K222593

TruPlan Computed Tomography (CT) Imaging Software

Circle Cardiovascular Imaging, Inc.

Visualization, measurement, pre-procedural planning and sizing, and post-procedural evaluation for left atrial appendage closure (LAAC); the software is a planning and assessment...

Modality
CT/CTA
Anatomy
Left atrial appendage and adjacent cardiac and extracardiac cardiovascular structures
Decision
2023-01-18
FDA-cleared K213998

cvi42 Auto Imaging Software Application

Circle Cardiovascular Imaging Inc

cvi42 Auto is intended to be used for viewing, post-processing, qualitative and quantitative evaluation of cardiovascular magnetic resonance (MR) and computed tomography (CT)...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Heart/Cardiovascular
Decision
2022-07-28
FDA-cleared K202212

TruPlan

Circle Cardiovascular Imaging Inc.

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

Modality
CT/CTA
Anatomy
Heart/Cardiovascular
Decision
2021-02-19
FDA-cleared K141480

CVI42

CIRCLE CARDIOVASCULAR IMAGING INC

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