Stockholm, SE · 6 510(k) clearances · 1 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | Class II | Radiology | 4 | 2025-09-09 |
| QIH | Automated Radiological Image Processing Software | Class II | Radiology | 2 | 2026-07-31 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-10-31 | Class II | Ongoing | Z-0678-2025 | Hybrid Recon software on Hermes Medical Imaging Suite version 6.1 Hybrid Recon software versions affected are 4.0.0x an… | — | Due a potential software/configuration issue that may result is incorrect alignment during reconstructing a SPECT/CT study. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-07-31 | K253835 | Affinity | QIH | Class II | Radiology |
| 2025-09-09 | K252477 | Hybrid Viewer (00859873006240) | KPS | Class II | Radiology |
| 2025-07-30 | K243919 | Voxel Dosimetry (00859873006226) | QIH | Class II | Radiology |
| 2024-11-08 | K241364 | Hybrid Viewer (00859873006189) | KPS | Class II | Radiology |
| 2020-12-23 | K202882 | Affinity | KPS | Class II | Radiology |
| 2020-02-14 | K193152 | Affinity | KPS | Class II | Radiology |