Plano, TX, US · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| IZL | System, X-Ray, Mobile | Class II | Radiology | 2 | 2025-05-28 |
| OWB | — | — | — | 1 | 2020-04-03 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | Class II | Radiology | 1 | 2020-02-14 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-05-28 | K244049 | Europa (Alternative: AiRTouch) portable X-ray system | IZL | Class II | Radiology |
| 2020-05-07 | K193535 | EZER, Portable X-ray System | IZL | Class II | Radiology |
| 2020-04-03 | K200022 | FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System | OWB | — | — |
| 2020-02-14 | K193644 | E-COM DR-2000 DR | MQB | Class II | Radiology |