Ever Fortune.Ai, Co., Ltd.
Medical device manufacturer in Taichung City, TW.
15510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K253163 | Efai Ersuite CT Appendicitis Assessment System (APPEN-CT-100)QAS · Traditional | 04/22/2026SE |
| K251306 | Seg Pro V3 (RT-300)QKB · Traditional | 01/28/2026SE |
| K242821 | EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)QAS · Traditional | 02/20/2025SE |
| K241923 | EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)QAS · Traditional | 12/06/2024SE |
| K234042 | EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)QIH · Traditional | 06/07/2024SE |
| K240291 | Efai Cardiosuite Cta Acute Aortic Syndrome Assessment SystemQAS · Traditional | 04/08/2024SE |
| K231025 | EFAI NeuroSuite CT ICH Assessment SystemQAS · Traditional | 10/04/2023SE |
| K231928 | EFAI RTSUITE CT HCAP-Segmentation SystemQKB · Special | 09/25/2023SE |
| K232100 | Efai Pacs Picture Archiving and Communication System ProLLZ · Special | 08/08/2023SE |
| K221552 | EFAI ChestSuite XR Pneumothorax Assessment SystemQFM · Traditional | 11/08/2022SE |
| K222076 | EFAI ChestSuite XR Pleural Effusion Assessment SystemQFM · Traditional | 09/08/2022SE |
| K213731 | EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile WorkflowsKPS · Traditional | 05/31/2022SE |
| K220264 | EFAI RTSuite CT HN-Segmentation SystemQKB · Traditional | 04/28/2022SE |
| K212624 | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemQIH · Traditional | 04/04/2022SE |
| K211257 | EFAI PACS Picture Archiving and Communication SystemLLZ · Traditional | 09/10/2021SE |