Bergen, NO · 5 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 3 | 2024-10-22 |
| LNH | — | — | — | 2 | 2026-03-20 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-06-16 | Class II | Terminated | Z-1462-2022 | nordicBrainEX, software versions 2.21 through 2.3.10 | — | When exporting merged results from the BOLD, DSC, and DCE modules of nordicBrainEx, where both the underlay and overlay originated from a multiframe dataset, th… |