Paris, FR · 7 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | Class II | Radiology | 4 | 2025-11-14 |
| KPR | System, X-Ray, Stationary | Class II | Radiology | 2 | 2024-08-06 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 1 | 2023-10-24 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2020-12-22 | Class II | Terminated | Z-1415-2021 | The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. T… | — | Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-P… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-11-14 | K251078 | AutoDensity | QIH | Class II | Radiology |
| 2025-08-15 | K251747 | VEA Align; spineEOS | QIH | Class II | Radiology |
| 2024-08-06 | K233920 | EOSedge | KPR | Class II | Radiology |
| 2024-06-25 | K240582 | VEA Align; spineEOS | QIH | Class II | Radiology |
| 2024-01-05 | K231917 | VEA Align | QIH | Class II | Radiology |
| 2023-10-24 | K232086 | spineEOS | LLZ | Class II | Radiology |
| 2020-09-16 | K202394 | EOSedge | KPR | Class II | Radiology |