Ever Fortune.Ai, Co., Ltd.
FDA 510(k) & PMA Approved Devices — 15 products
Total Devices15
Categories6
Latest Approval2026-04-22
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K253163 | EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) | QAS | 2026-04-22 | View |
| 510(k) | K251306 | Seg Pro V3 (RT-300) | QKB | 2026-01-28 | View |
| 510(k) | K242821 | EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) | QAS | 2025-02-20 | View |
| 510(k) | K241923 | EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) | QAS | 2024-12-06 | View |
| 510(k) | K234042 | EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) | QIH | 2024-06-07 | View |
| 510(k) | K240291 | EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM | QAS | 2024-04-08 | View |
| 510(k) | K231025 | EFAI NeuroSuite CT ICH Assessment System | QAS | 2023-10-04 | View |
| 510(k) | K231928 | EFAI RTSUITE CT HCAP-Segmentation System | QKB | 2023-09-25 | View |
| 510(k) | K232100 | Efai Pacs Picture Archiving and Communication System Pro | LLZ | 2023-08-08 | View |
| 510(k) | K221552 | EFAI ChestSuite XR Pneumothorax Assessment System | QFM | 2022-11-08 | View |
| 510(k) | K222076 | EFAI ChestSuite XR Pleural Effusion Assessment System | QFM | 2022-09-08 | View |
| 510(k) | K213731 | EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows | KPS | 2022-05-31 | View |
| 510(k) | K220264 | EFAI RTSuite CT HN-Segmentation System | QKB | 2022-04-28 | View |
| 510(k) | K212624 | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System | QIH | 2022-04-04 | View |
| 510(k) | K211257 | EFAI PACS Picture Archiving and Communication System | LLZ | 2021-09-10 | View |
No matching devices.