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
Vendor
TeraRecon Inc.
6 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K200750
Neuro.Al Algorithm
TeraRecon, Inc.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2020-11-06
FDA-cleared K220349
TeraRecon Neuro
TeraRecon, Inc
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-08-12
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 K243158
TeraRecon Aorta.CT (1.1.0)
TeraRecon, Inc.
Image analysis/processing for Cardiovascular using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Cardiovascular
- Decision
- 2025-01-23
FDA-cleared K250288
TeraRecon Cardiovascular.Calcification.CT
Terarecon,Inc.
Image analysis/processing for Vascular using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Vascular
- Decision
- 2025-10-23