Dayton, OH, US · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | Class II | Radiology | 3 | 2023-07-12 |
| KPR | System, X-Ray, Stationary | Class II | Radiology | 2 | 2023-10-25 |
| IZL | System, X-Ray, Mobile | Class II | Radiology | 1 | 2020-04-13 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-10-25 | K231995 | AcuityUDR | KPR | Class II | Radiology |
| 2023-07-12 | K231709 | AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 | MQB | Class II | Radiology |
| 2021-04-30 | K210919 | AcuityDRe | MQB | Class II | Radiology |
| 2020-05-06 | K201058 | Accuvue+ | MQB | Class II | Radiology |
| 2020-04-13 | K200726 | AcuityPDR | IZL | Class II | Radiology |
| 2020-01-02 | K193360 | Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard | KPR | Class II | Radiology |