Ever Fortune.Ai, Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 14
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251306 | Seg Pro V3 (RT-300) | January 28, 2026 |
| K242821 | EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) | February 20, 2025 |
| K241923 | EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) | December 6, 2024 |
| K234042 | EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) | June 7, 2024 |
| K240291 | EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM | April 8, 2024 |
| K231025 | EFAI NeuroSuite CT ICH Assessment System | October 4, 2023 |
| K231928 | EFAI RTSUITE CT HCAP-Segmentation System | September 25, 2023 |
| K232100 | Efai Pacs Picture Archiving and Communication System Pro | August 8, 2023 |
| K221552 | EFAI ChestSuite XR Pneumothorax Assessment System | November 8, 2022 |
| K222076 | EFAI ChestSuite XR Pleural Effusion Assessment System | September 8, 2022 |
| K213731 | EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows | May 31, 2022 |
| K220264 | EFAI RTSuite CT HN-Segmentation System | April 28, 2022 |
| K212624 | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System | April 4, 2022 |
| K211257 | EFAI PACS Picture Archiving and Communication System | September 10, 2021 |