Medical Device Manufacturer · TW , Taichung City

Ever Fortune.Ai, Co., Ltd. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2021
14
Total
14
Cleared
0
Denied

Ever Fortune.Ai, Co., Ltd. has 14 FDA 510(k) cleared radiology devices. Based in Taichung City, TW.

Latest FDA clearance: Jan 2026. Active since 2021.

Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.

14 devices
1–12 of 14
Seg Pro V3 (RT-300)
K251306 · QKB Radiological Image Processing Software For Radiation Therapy · Radiology
Jan 2026 275d
EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
K242821 · QAS Radiological Computer-assisted Triage And Notification Software · Radiology
Feb 2025 155d
EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)
K241923 · QAS Radiological Computer-assisted Triage And Notification Software · Radiology
Dec 2024 158d
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
K234042 · QIH Automated Radiological Image Processing Software · Radiology
Jun 2024 169d
EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM
K240291 · QAS Radiological Computer-assisted Triage And Notification Software · Radiology
Apr 2024 67d
EFAI NeuroSuite CT ICH Assessment System
K231025 · QAS Radiological Computer-assisted Triage And Notification Software · Radiology
Oct 2023 176d
EFAI RTSUITE CT HCAP-Segmentation System
K231928 · QKB Radiological Image Processing Software For Radiation Therapy · Radiology
Sep 2023 87d
Efai Pacs Picture Archiving and Communication System Pro
K232100 · LLZ System, Image Processing, Radiological · Radiology
Aug 2023 25d
EFAI ChestSuite XR Pneumothorax Assessment System
K221552 · QFM Radiological Computer-assisted Prioritization Software For Lesions · Radiology
Nov 2022 161d
EFAI ChestSuite XR Pleural Effusion Assessment System
K222076 · QFM Radiological Computer-assisted Prioritization Software For Lesions · Radiology
Sep 2022 56d
EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows
K213731 · KPS System, Tomography, Computed, Emission · Radiology
May 2022 186d
EFAI RTSuite CT HN-Segmentation System
K220264 · QKB Radiological Image Processing Software For Radiation Therapy · Radiology
Apr 2022 87d
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