Radiology AI Directory
Tools Buyer index FDA-cleared Sponsor Reimbursement Claim profile

Use case

Cardiac imaging radiology AI tools

A buyer-oriented shortlist for cardiac imaging. Confirm exact intended use and local validation needs before any pilot or procurement decision.

FDA-cleared K161382

LVivo Software Application

DIACARDIO, LTD.

LVivo Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular...

Modality
MRI
Anatomy
Heart
Decision
2016-07-28
Cardiac imagingDetection and CADeQuantification and segmentation
FDA-cleared K191585

iNtuition-Structural Heart Module

TeraRecon Inc.

Image analysis/processing for Heart using Radiotherapy planning imaging.

Modality
Radiotherapy planning imaging
Anatomy
Heart
Decision
2019-07-12
Radiotherapy planningCardiac imaging
FDA-cleared K183274

RTHawk, HeartVista Cardiac Package

HeartVista, Inc.

Image analysis/processing for Heart using MRI.

Modality
MRI
Anatomy
Heart
Decision
2019-10-18
Cardiac imaging
FDA-cleared K223855

FEops HEARTguideTM, FEops HEARTguideTM ALPACA

FEops nv

Image analysis/processing for Heart using CT/CTA.

Modality
CT/CTA
Anatomy
Heart
Decision
2023-06-06
Cardiac imaging
FDA-cleared K241038

Cardiac CT Function Software Application

Circle Cardiovascular Imaging

Image analysis/processing for Heart using CT/CTA.

Modality
CT/CTA
Anatomy
Heart
Decision
2024-06-07
Cardiac imaging
FDA-cleared K241380

FETOLY-HEART

Diagnoly

Image analysis/processing for Heart using Ultrasound.

Modality
Ultrasound
Anatomy
Heart
Decision
2024-09-11
Cardiac imagingUltrasound workflow
FDA-cleared K241312

TeraRecon Cardiac.Chambers.MR (1.0.0)

TeraRecon,Inc.

Image analysis/processing for Heart using MRI.

Modality
MRI
Anatomy
Heart
Decision
2024-11-05
Cardiac imaging
FDA-cleared K243065

Cardiac Guidance

Caption Health, Inc.

Image analysis/processing for Heart using Mammography/DBT.

Modality
Mammography/DBT
Anatomy
Heart
Decision
2025-01-15
Breast imagingCardiac imaging
FDA-cleared K242807

HeartFocus (V.1.1.1)

Deski

Image analysis/processing for Heart using Mammography/DBT.

Modality
Mammography/DBT
Anatomy
Heart
Decision
2025-04-04
Breast imagingCardiac imaging
FDA-cleared K251837

Salix Coronary Plaque (V1.0.0)

Artrya Limited

Image analysis/processing for Heart using CT/CTA.

Modality
CT/CTA
Anatomy
Heart
Decision
2025-08-20
Cardiac imaging
FDA-cleared K251656

Careverse CoronaryDoc (Careverse CoronaryDoc)

Careverse Technology Pte. Ltd.

Image analysis/processing for Heart using CT/CTA.

Modality
CT/CTA
Anatomy
Heart
Decision
2025-09-04
Cardiac imaging
FDA-cleared K252105

Ligence Heart

Ligence, UAB

Image analysis/processing for Heart using Radiotherapy planning imaging.

Modality
Radiotherapy planning imaging
Anatomy
Heart
Decision
2025-09-26
Radiotherapy planningCardiac imaging
FDA-cleared K251027

cvi42 Coronary Plaque Software Application

Circle Cardiovascular Imaging, Inc.

Image analysis/processing for Heart using CT/CTA.

Modality
CT/CTA
Anatomy
Heart
Decision
2025-10-27
Cardiac imaging
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