| Decision | Number | Device | Company | Panel |
|---|---|---|---|---|
| 2025-10-23 | K250288 | TeraRecon Cardiovascular.Calcification.CT | Terarecon,Inc. | Radiology |
| 2025-01-23 | K243158 | TeraRecon Aorta.CT (1.1.0) | TeraRecon, Inc. | Radiology |
| 2024-11-05 | K241312 | TeraRecon Cardiac.Chambers.MR (1.0.0) | TeraRecon,Inc. | Radiology |
| 2022-08-12 | K220349 | TeraRecon Neuro | TeraRecon, Inc | Radiology |
| 2020-11-06 | K200750 | Neuro.Al Algorithm | TeraRecon, Inc. | Radiology |
| 2019-07-12 | K191585 | iNtuition-Structural Heart Module | TeraRecon Inc. | Radiology |