Cambridge, MA, US · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QYE | — | — | — | 2 | 2025-07-28 |
| QIH | Automated Radiological Image Processing Software | Class II | Radiology | 1 | 2026-06-15 |
| SHP | Cardiac Amyloidosis Machine Learning-Based Notification Software | Class II | Cardiovascular | 1 | 2026-04-07 |
| SAT | — | — | — | 1 | 2026-03-28 |
| DQK | Computer, Diagnostic, Programmable | Class II | Cardiovascular | 1 | 2023-11-25 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-15 | K260300 | WatchMate Software | QIH | Class II | Radiology |
| 2026-04-07 | K253801 | ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) | SHP | Class II | Cardiovascular |
| 2026-03-28 | K252360 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | SAT | — | — |
| 2025-07-28 | K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | QYE | — | — |
| 2023-11-25 | K233160 | NeuTrace EP Mapping System v.2.1 | DQK | Class II | Cardiovascular |
| 2023-09-28 | K232699 | Low Ejection Fraction AI-ECG Algorithm | QYE | — | — |