| EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) (K253163) | Ever Fortune.Ai, Co., Ltd. | 2026-04-22 |
| Seg Pro V3 (RT-300) (K251306) | Ever Fortune.Ai, Co., Ltd. | 2026-01-28 |
| EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) (K242821) | Ever Fortune.Ai, Co., Ltd. | 2025-02-20 |
| EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) (K241923) | Ever Fortune.Ai, Co., Ltd. | 2024-12-06 |
| EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) (K234042) | Ever Fortune.Ai, Co., Ltd. | 2024-06-07 |
| EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM (K240291) | Ever Fortune.Ai, Co., Ltd. | 2024-04-08 |
| EFAI NeuroSuite CT ICH Assessment System (K231025) | Ever Fortune.Ai, Co., Ltd. | 2023-10-04 |
| EFAI RTSUITE CT HCAP-Segmentation System (K231928) | Ever Fortune.Ai, Co., Ltd. | 2023-09-25 |
| Efai Pacs Picture Archiving and Communication System Pro (K232100) | Ever Fortune.Ai, Co., Ltd. | 2023-08-08 |
| EFAI ChestSuite XR Pneumothorax Assessment System (K221552) | Ever Fortune.Ai, Co., Ltd. | 2022-11-08 |
| EFAI ChestSuite XR Pleural Effusion Assessment System (K222076) | Ever Fortune.Ai, Co., Ltd. | 2022-09-08 |
| EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows (K213731) | Ever Fortune.Ai, Co., Ltd. | 2022-05-31 |
| EFAI RTSuite CT HN-Segmentation System (K220264) | Ever Fortune.Ai, Co., Ltd. | 2022-04-28 |
| EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System (K212624) | Ever Fortune.Ai, Co., Ltd. | 2022-04-04 |
| EFAI PACS Picture Archiving and Communication System (K211257) | Ever Fortune.Ai, Co., Ltd. | 2021-09-10 |