| Decision | Number | Device | Company | Panel |
|---|---|---|---|---|
| 2026-05-27 | K254075 | Synapse Lung Nodule AI | Fujifilm Corporation | Radiology |
| 2026-04-30 | K254189 | Synapse 3D Base Tools (V7.2) | Fujifilm Corporation | Radiology |
| 2025-09-17 | K251386 | ECHELON Synergy | Fujifilm Corporation | Radiology |
| 2025-05-21 | K243762 | Synapse 3D Base Tools (V7.0) | FUJIFILM Corporation | Radiology |
| 2025-05-20 | K250370 | SCENARIA View Phase 5.0 | FUJIFILM Corporation | Radiology |
| 2023-12-15 | K230751 | EW10-EC02 Endoscopy Support Program | FUJIFILM Corporation | Gastroenterology-Urology |
| 2021-02-09 | K203103 | Synapse 3D, Synapse 3D Base Tools v6.1 | Fujifilm Corporation | Radiology |