FDA-cleared K250288
TeraRecon Cardiovascular.Calcification.CT
Terarecon,Inc.
Automatic coronary-artery calcium plaque segmentation for downstream calcium scoring.
- Modality
- CT/CTA
- Anatomy
- Heart/Coronary Arteries
- Decision
- 2025-10-23
Vendor
Terarecon,Inc.
6 FDA-cleared listings in this directory.
Claim vendor profile FDA-cleared K243158
TeraRecon Aorta.CT (1.1.0)
TeraRecon, Inc.
TeraRecon Aorta.CT (1.1.0) automatically segments the aorta and labels 22 aortic anatomical landmarks from adult contrast CTA DICOM for trained professionals' review in...
- Modality
- CT/CTA
- Anatomy
- Heart/Cardiovascular
- Decision
- 2025-01-23
FDA-cleared K241312
TeraRecon Cardiac.Chambers.MR (1.0.0)
TeraRecon,Inc.
Provide cardiac-chamber segmentations for trained healthcare professionals reviewing adult cardiac MR to assist diagnosis or treatment planning; the physician makes final...
- Modality
- MRI
- Anatomy
- Cardiac chambers: left-ventricular myocardium and chamber, and right-ventricular chamber for the Cine-ax component; left-ventricular myocardium and chamber for the De-ax component.
- Decision
- 2024-11-05
FDA-cleared K220349
TeraRecon Neuro
TeraRecon, Inc
The TeraRecon Neuro algorithm is an algorithm for use by trained professionals, including but not limited to physicians, surgeons and medical clinicians. The TeraRecon Neuro...
- Modality
- Radiological images; modality varies or is not specified in FDA list
- Anatomy
- Brain
- Decision
- 2022-08-12
FDA-cleared K200750
Neuro.Al Algorithm
TeraRecon, Inc.
Neuro.Al Algorithm processes static, functional, dynamic, and derived CT or MR images to support brain perfusion analysis, tissue blood-volume and parametric-map review,...
- Modality
- Radiological images; modality varies or is not specified in FDA list
- Anatomy
- Brain and intracranial perfusion regions
- Decision
- 2020-11-06
FDA-cleared K191585
iNtuition-Structural Heart Module
TeraRecon Inc.
iNutrition-Structural Heart Module is a software solution that is intended to assist Cardiologists, Radiologists and clinical specialists with the visualization and measurements...
- Modality
- Radiological images; modality varies or is not specified in FDA list
- Anatomy
- Heart/Cardiovascular
- Decision
- 2019-07-12