← Every applicant
Ever Fortune.Ai, Co., Ltd. FDA Approvals
0 new drug approvals and 15 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)510(k)Apr 22, 2026Radiology |
| Seg Pro V3 (RT-300)510(k)Jan 28, 2026Radiology |
| EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)510(k)Feb 20, 2025Radiology |
| EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)510(k)Dec 6, 2024Radiology |
| EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)510(k)Jun 7, 2024Radiology |
| EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM510(k)Apr 8, 2024Radiology |
| EFAI NeuroSuite CT ICH Assessment System510(k)Oct 4, 2023Radiology |
| EFAI RTSUITE CT HCAP-Segmentation System510(k)Sep 25, 2023Radiology |
| Efai Pacs Picture Archiving and Communication System Pro510(k)Aug 8, 2023Radiology |
| EFAI ChestSuite XR Pneumothorax Assessment System510(k)Nov 8, 2022Radiology |
| EFAI ChestSuite XR Pleural Effusion Assessment System510(k)Sep 8, 2022Radiology |
| EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows510(k)May 31, 2022Radiology |
| EFAI RTSuite CT HN-Segmentation System510(k)Apr 28, 2022Radiology |
| EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System510(k)Apr 4, 2022Radiology |
| EFAI PACS Picture Archiving and Communication System510(k)Sep 10, 2021Radiology |