Malvern, PA, US · 7 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| KPR | System, X-Ray, Stationary | Class II | Radiology | 3 | 2025-07-31 |
| OWB | — | — | — | 3 | 2025-07-14 |
| IZL | System, X-Ray, Mobile | Class II | Radiology | 1 | 2023-07-25 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-07-31 | K250738 | YSIO X.pree | KPR | Class II | Radiology |
| 2025-07-14 | K250660 | LUMINOS Q.namix T; LUMINOS Q.namix R | OWB | — | — |
| 2024-05-21 | K233543 | YSIO X.pree | KPR | Class II | Radiology |
| 2023-11-29 | K233532 | MULTIX Impact E | KPR | Class II | Radiology |
| 2023-07-25 | K231577 | MOBILETT Impact | IZL | Class II | Radiology |
| 2022-11-17 | K221281 | Multitom Rax | OWB | — | — |
| 2022-02-18 | K212212 | Multitom Rax with True2scale Body Scan Option | OWB | — | — |