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| 2026-01-28 | K251306 | Seg Pro V3 (RT-300) | Ever Fortune.Ai, Co., Ltd. | Radiology |
| 2025-02-20 | K242821 | EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) | Ever Fortune.AI, Co., Ltd. | Radiology |
| 2024-12-06 | K241923 | EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) | Ever Fortune.AI, Co., Ltd. | Radiology |
| 2024-06-07 | K234042 | EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) | Ever Fortune.AI Co., Ltd. | Radiology |
| 2024-04-08 | K240291 | EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM | Ever Fortune.AI, Co., Ltd. | Radiology |
| 2023-10-04 | K231025 | EFAI NeuroSuite CT ICH Assessment System | Ever Fortune.AI Co., Ltd. | Radiology |
| 2023-09-25 | K231928 | EFAI RTSUITE CT HCAP-Segmentation System | Ever Fortune.AI Co., Ltd. | Radiology |
| 2022-11-08 | K221552 | EFAI ChestSuite XR Pneumothorax Assessment System | Ever Fortune AI Co., Ltd. | Radiology |
| 2022-09-08 | K222076 | EFAI ChestSuite XR Pleural Effusion Assessment System | Ever Fortune.AI Co., Ltd. | Radiology |
| 2022-04-28 | K220264 | EFAI RTSuite CT HN-Segmentation System | Ever Fortune.AI Co., Ltd. | Radiology |
| 2022-04-04 | K212624 | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System | Ever Fortune. AI Co., Ltd. | Radiology |