Brisbane, CA, US · 6 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QJU | — | — | — | 3 | 2025-01-15 |
| QIH | Automated Radiological Image Processing Software | Class II | Radiology | 2 | 2022-01-19 |
| QVD | Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan | Class II | Radiology | 1 | 2023-02-24 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2021-05-19 | Class II | Terminated | Z-2111-2021 | Version: 1.2.0 (1.2.0+85ela410) Caption Health, Caption AI, Ultrasound Imaging System Application Software (GMDN: 40873)… | — | The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect automated eject… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-01-15 | K243065 | Cardiac Guidance | QJU | — | — |
| 2023-02-24 | DEN220063 | Caption Interpretation Automated Ejection Fraction Software | QVD | Class II | Radiology |
| 2022-01-19 | K210747 | Caption Interpretation Automated Ejection Fraction Software | QIH | Class II | Radiology |
| 2020-09-18 | K201992 | Caption Guidance | QJU | — | — |
| 2020-07-22 | K200621 | Caption Interpretation Automated Ejection Fraction Software | QIH | Class II | Radiology |
| 2020-04-16 | K200755 | Caption Guidance | QJU | — | — |