Ever Fortune.Ai, Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100), Seg Pro V3 (RT-300), EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
15
Total
15
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ever Fortune.Ai, Co., Ltd. Radiology ✕
15 devices
Cleared
Apr 22, 2026
EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)
Radiology
208d
Cleared
Jan 28, 2026
Seg Pro V3 (RT-300)
Radiology
275d
Cleared
Feb 20, 2025
EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
Radiology
155d
Cleared
Dec 06, 2024
EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)
Radiology
158d
Cleared
Jun 07, 2024
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
Radiology
169d
Cleared
Apr 08, 2024
EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM
Radiology
67d
Cleared
Oct 04, 2023
EFAI NeuroSuite CT ICH Assessment System
Radiology
176d
Cleared
Sep 25, 2023
EFAI RTSUITE CT HCAP-Segmentation System
Radiology
87d
Cleared
Aug 08, 2023
Efai Pacs Picture Archiving and Communication System Pro
Radiology
25d
Cleared
Nov 08, 2022
EFAI ChestSuite XR Pneumothorax Assessment System
Radiology
161d
Cleared
Sep 08, 2022
EFAI ChestSuite XR Pleural Effusion Assessment System
Radiology
56d
Cleared
May 31, 2022
EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows
Radiology
186d