Durham, NC, US · 5 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | Class II | Radiology | 3 | 2025-10-23 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 2 | 2022-08-12 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-10-23 | K250288 | TeraRecon Cardiovascular.Calcification.CT | QIH | Class II | Radiology |
| 2025-01-23 | K243158 | TeraRecon Aorta.CT (1.1.0) | QIH | Class II | Radiology |
| 2024-11-05 | K241312 | TeraRecon Cardiac.Chambers.MR (1.0.0) | QIH | Class II | Radiology |
| 2022-08-12 | K220349 | TeraRecon Neuro | LLZ | Class II | Radiology |
| 2020-11-06 | K200750 | Neuro.Al Algorithm | LLZ | Class II | Radiology |