Company ยท TW
Ever Fortune.Ai, Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2021 to 2026. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (3 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| QAS | Radiological Computer-Assisted Triage And Notification Software | 6 |
| QKB | Radiological Image Processing Software For Radiation Therapy | 3 |
| LLZ | System, Image Processing, Radiological | 2 |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | 2 |
| QIH | Automated Radiological Image Processing Software | 2 |
| KPS | System, Tomography, Computed, Emission | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 30, 2026 | K263109 | EFAI NEUROSUITE CTA LVO ASSESSMENT SYSTEM (LVO-CTA-100) Ever Fortune.Ai, Co., Ltd., TW | QAS |
| Apr 22, 2026 | K253163 | EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) Ever Fortune.Ai, Co., Ltd., TW | QAS |
| Jan 28, 2026 | K251306 | Seg Pro V3 (RT-300) Ever Fortune.Ai, Co., Ltd., TW | QKB |
| Feb 20, 2025 | K242821 | EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) Ever Fortune.Ai, Co., Ltd., TW | QAS |
| Dec 6, 2024 | K241923 | EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) Ever Fortune.Ai, Co., Ltd., TW | QAS |
| Jun 7, 2024 | K234042 | EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) Ever Fortune.Ai, Co., Ltd., TW | QIH |
| Apr 8, 2024 | K240291 | EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM Ever Fortune.Ai, Co., Ltd., TW | QAS |
| Oct 4, 2023 | K231025 | EFAI NeuroSuite CT ICH Assessment System Ever Fortune.Ai, Co., Ltd., TW | QAS |
| Sep 25, 2023 | K231928 | EFAI RTSUITE CT HCAP-Segmentation System Ever Fortune.Ai, Co., Ltd., TW | QKB |
| Aug 8, 2023 | K232100 | Efai Pacs Picture Archiving and Communication System Pro Ever Fortune.Ai, Co., Ltd., TW | LLZ |
| Nov 8, 2022 | K221552 | EFAI ChestSuite XR Pneumothorax Assessment System Ever Fortune.Ai, Co., Ltd., TW | QFM |
| Sep 8, 2022 | K222076 | EFAI ChestSuite XR Pleural Effusion Assessment System Ever Fortune.Ai, Co., Ltd., TW | QFM |
| May 31, 2022 | K213731 | EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows Ever Fortune.Ai, Co., Ltd., TW | KPS |
| Apr 28, 2022 | K220264 | EFAI RTSuite CT HN-Segmentation System Ever Fortune.Ai, Co., Ltd., TW | QKB |
| Apr 4, 2022 | K212624 | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System Ever Fortune.Ai, Co., Ltd., TW | QIH |
| Sep 10, 2021 | K211257 | EFAI PACS Picture Archiving and Communication System Ever Fortune.Ai, Co., Ltd., TW | LLZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||