Vendor
6 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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Terarecon,Inc.
Authorized purpose: Automatic coronary-artery calcium plaque segmentation for downstream calcium scoring.
TeraRecon, Inc.
Authorized purpose: 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 standard-of-care planning; it does not alter the original images or provide a diagnosis and excludes the FDA-listed device/anatomy conditions.
TeraRecon,Inc.
Authorized purpose: Provide cardiac-chamber segmentations for trained healthcare professionals reviewing adult cardiac MR to assist diagnosis or treatment planning; the physician makes final patient-management decisions.
TeraRecon, Inc
Authorized purpose: Analyzes functional, dynamic, and derived CT or MRI datasets for brain perfusion, vascular assessment, tissue blood volume, and related parametric maps to assist physician diagnosis.
TeraRecon, Inc.
Authorized purpose: 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, ventricular visualization, and DICOM return to clinical viewers for trained professional interpretation.
TeraRecon Inc.
Authorized purpose: Visualizes and measures heart and vessel structures.