FDA Registration
Active
🇹🇼 Taiwan
EverFortune.AI Co., Ltd.
Reg #: 3021032044
·
FEI: 3021032044
·
Expires 2026
Products
6
Proprietary Names
12
Establishment Types
1
Classifications
6
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Registration Details
- Registration Name
- EverFortune.AI Co., Ltd.
- Registration Number
- 3021032044
- FEI Number
- 3021032044
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8F., No. 360, Sec. 1, Jingmao Rd., Beitun Dist.
- City
- TAICHUNG CITY
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K222076
Owner / Operator
- Firm Name
- Ever Fortune.AI Co., Ltd.
- Operator Number
- 10083078
- Address
- 8F., No. 360, Sec. 1, Jingmao Rd., Beitun Dist.
- City
- TAICHUNG CITY
- State
- TW-TXG
- Postal Code
- 406040
- Country
- TW
- Correspondent
- RA Dept. Ever Fortune.AI
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radiological Computer-Assisted Prioritization Software For Lesions | QFM | Class 2 | Radiology | No | 2022-12-28 |
| Radiological Computer-Assisted Triage And Notification Software | QAS | Class 2 | Radiology | No | 2025-03-10 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2021-10-24 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2024-11-14 |
| Radiological Image Processing Software For Radiation Therapy | QKB | Class 2 | Radiology | No | 2023-12-27 |
| System, Tomography, Computed, Emission | KPS | Class 2 | Radiology | No | 2022-12-28 |
Proprietary Names
EFAI ChestSuite XR Pleural Effusion Assessment System
EFAI Chestsuite XR Malpositioned ETT Assessment System
EFAI PACS Picture Archiving and Communication System
EFAI Bonesuite XR Bone Age Pro Assessment System
EFAI Neurosuite CT Midline Shift Assessment System
EFAI RTSUITE CT HCAP-Segmentation System
EFAI NeuroSuite CT ICH Assessment System
Efai Pacs Picture Archiving and Communication System Pro
EFAI RTSuite CT HN-Segmentation System
EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows
EFAI ChestSuite XR Pneumothorax Assessment System
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
Establishment Types
Manufacture Medical Device