Data / Medical devices / Taiwan / EverFortune.AI Co., Ltd.
EverFortune.AI Co., Ltd.: FDA-registered device maker in Taichung City, Taiwan, 14 510(k) clearances
EverFortune.AI Co., Ltd. is registered with the FDA (registration 3021032044) in Taichung City, Taiwan. It lists 6 device types. The FDA files 14 510(k) clearances under its listings, the newest dated January 28, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021032044
- Address
- 8F., No. 360, Sec. 1, Jingmao Rd., Beitun Dist., Taichung City, Taiwan, 406040
- Owner or operator
- Ever Fortune.AI Co., Ltd. (10083078)
- Roles
- Manufacturer
- First device listed
- October 24, 2021
- Registered through
- 2026
- Brand names listed
- EFAI Bonesuite XR Bone Age Pro Assessment System, EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows, EFAI ChestSuite XR Pleural Effusion Assessment System, EFAI ChestSuite XR Pneumothorax Assessment System, EFAI Chestsuite XR Malpositioned ETT Assessment System, EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System, EFAI NeuroSuite CT ICH Assessment System, EFAI Neurosuite CT Midline Shift Assessment System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Radiological Computer-Assisted Prioritization Software For Lesions | QFM | 2 | Manufacturer | accessdata.fda.gov |
| Radiological Computer-Assisted Triage And Notification Software | QAS | 2 | Manufacturer | accessdata.fda.gov |
| Radiological Image Processing Software For Radiation Therapy | QKB | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, Tomography, Computed, Emission | KPS | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 28, 2026 | K251306 | Seg Pro V3 (RT-300) | QKB | Substantially Equivalent | Ever Fortune.Ai, Co., Ltd. | accessdata.fda.gov |
| February 20, 2025 | K242821 | EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) | QAS | Substantially Equivalent | Ever Fortune.Ai, Co., Ltd. | accessdata.fda.gov |
| December 6, 2024 | K241923 | EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) | QAS | Substantially Equivalent | Ever Fortune.Ai, Co., Ltd. | accessdata.fda.gov |
| June 7, 2024 | K234042 | EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) | QIH | Substantially Equivalent | Ever Fortune.Ai, Co., Ltd. | accessdata.fda.gov |
| April 8, 2024 | K240291 | EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM | QAS | Substantially Equivalent | Ever Fortune.Ai, Co., Ltd. | accessdata.fda.gov |
| October 4, 2023 | K231025 | EFAI NeuroSuite CT ICH Assessment System | QAS | Substantially Equivalent | Ever Fortune.Ai, Co., Ltd. | accessdata.fda.gov |
| September 25, 2023 | K231928 | EFAI RTSUITE CT HCAP-Segmentation System | QKB | Substantially Equivalent | Ever Fortune.Ai, Co., Ltd. | accessdata.fda.gov |
| August 8, 2023 | K232100 | Efai Pacs Picture Archiving and Communication System Pro | LLZ | Substantially Equivalent | Ever Fortune.Ai, Co., Ltd. | accessdata.fda.gov |
| November 8, 2022 | K221552 | EFAI ChestSuite XR Pneumothorax Assessment System | QFM | Substantially Equivalent | Ever Fortune.Ai, Co., Ltd. | accessdata.fda.gov |
| September 8, 2022 | K222076 | EFAI ChestSuite XR Pleural Effusion Assessment System | QFM | Substantially Equivalent | Ever Fortune.Ai, Co., Ltd. | accessdata.fda.gov |
| May 31, 2022 | K213731 | EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows | KPS | Substantially Equivalent | Ever Fortune.Ai, Co., Ltd. | accessdata.fda.gov |
| April 28, 2022 | K220264 | EFAI RTSuite CT HN-Segmentation System | QKB | Substantially Equivalent | Ever Fortune.Ai, Co., Ltd. | accessdata.fda.gov |
| April 4, 2022 | K212624 | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System | QIH | Substantially Equivalent | Ever Fortune.Ai, Co., Ltd. | accessdata.fda.gov |
| September 10, 2021 | K211257 | EFAI PACS Picture Archiving and Communication System | LLZ | Substantially Equivalent | Ever Fortune.Ai, Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Radiological Computer-Assisted Prioritization Software For Lesions
- All makers of Radiological Image Processing Software For Radiation Therapy
- All makers of Radiological Computer-Assisted Triage And Notification Software
- All makers of System, Image Processing, Radiological
- All makers of System, Tomography, Computed, Emission
- All makers of Automated Radiological Image Processing Software
Updated January 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.