Chicago, IL, US · 5 510(k) clearances · 1 PMAs
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| SBQ | Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software | Class II | Cardiovascular | 2 | 2026-09-25 |
| SAT | Pulmonary Hypertension Machine Learning-Based Notification Software | Class II | Cardiovascular | 1 | 2026-08-21 |
| PZM | Next Generation Sequencing Based Tumor Profiling Test | Class II | Pathology | 1 | 2025-09-19 |
| QYE | Reduced Ejection Fraction Machine Learning-Based Notification Software | Class II | Cardiovascular | 1 | 2025-07-15 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-09-02 | P210011-S002 | xT CDx | Normal 180 Day Track | PQP | Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System | Unknown |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-09-25 | K254297 | Tempus ECG-MR | SBQ | Class II | Cardiovascular |
| 2026-08-21 | K253699 | Tempus ECG-PH | SAT | Class II | Cardiovascular |
| 2025-09-19 | K241868 | xR IVD | PZM | Class II | Pathology |
| 2025-07-15 | K250119 | Tempus ECG-Low EF | QYE | Class II | Cardiovascular |
| 2024-06-21 | K233549 | Tempus ECG-AF | SBQ | Class II | Cardiovascular |