Garner, NC, US · 6 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| KPR | System, X-Ray, Stationary | Class II | Radiology | 3 | 2022-07-27 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | Class II | Radiology | 2 | 2026-06-12 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 1 | 2021-12-10 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2021-12-03 | Class II | Terminated | Z-0500-2022 | ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on displa… | — | lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential risk of incorrect length measurement/area calculation if incorrect power seq… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-12 | K252996 | Universal 1417PI | MQB | Class II | Radiology |
| 2022-07-27 | K221853 | OTC DDR | KPR | Class II | Radiology |
| 2022-01-21 | K214030 | Universal DR 1748 | MQB | Class II | Radiology |
| 2022-01-12 | K214012 | Straight Arm DDR | KPR | Class II | Radiology |
| 2021-12-10 | K203743 | EXA | LLZ | Class II | Radiology |
| 2020-01-15 | K193225 | KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography | KPR | Class II | Radiology |