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
FDA-cleared profile
LVivo Software Application
LVivo Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation.
Buyer-fit notes
LVivo Software Application is best reviewed for MRI Heart teams evaluating cardiac imaging tools with FDA source traceability.
Not ideal for buyers who need public price benchmarks before vendor contact or teams requiring confirmed deployment details before shortlist review.
FDA and evidence source ledger
Clinical use
LVivo Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation.
Alternatives
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RTHawk, HeartVista Cardiac Package
HeartVista, Inc.
Image analysis/processing for Heart using MRI.
- Modality
- MRI
- Anatomy
- Heart
- Decision
- 2019-10-18
FDA-cleared K170981
NeuroQuant
CorTechs Labs, Inc
is a fully automat ed MR imaging post -processing medical device software that provides automatic labeling, visualization and volumetric quantification of brain structures and...
- Modality
- MRI
- Anatomy
- Brain
- Decision
- 2017-09-07
FDA-cleared K163013
Quantib Brain 1.2
Quantib BV
Quantib Brain is post-processing analysis software for the GE Advantage Workstation (AW 4.7) and AW Server (AWS 3.2) platforms using Volume Viewer Apps. 12.3 Ext 8 (or higher).
- Modality
- MRI
- Anatomy
- Brain
- Decision
- 2017-01-06