Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ever Fortune.Ai, Co., Ltd. — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
158 daysmedian FDA review time
229 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253163 | EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100 | Ever Fortune.Ai, Co., Ltd. | 2026-04-22 | 208 | 0 |
| K251306 | Seg Pro V3 (RT-300) | Ever Fortune.Ai, Co., Ltd. | 2026-01-28 | 275 | 0 |
| K242821 | EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT- | Ever Fortune.Ai, Co., Ltd. | 2025-02-20 | 155 | 0 |
| K241923 | EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-1 | Ever Fortune.Ai, Co., Ltd. | 2024-12-06 | 158 | 0 |
| K234042 | EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100 | Ever Fortune.Ai, Co., Ltd. | 2024-06-07 | 169 | 0 |
| K240291 | EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM | Ever Fortune.Ai, Co., Ltd. | 2024-04-08 | 67 | 0 |
| K231025 | EFAI NeuroSuite CT ICH Assessment System | Ever Fortune.Ai, Co., Ltd. | 2023-10-04 | 176 | 0 |
| K231928 | EFAI RTSUITE CT HCAP-Segmentation System | Ever Fortune.Ai, Co., Ltd. | 2023-09-25 | 87 | 0 |
| K232100 | Efai Pacs Picture Archiving and Communication System Pro | Ever Fortune.Ai, Co., Ltd. | 2023-08-08 | 25 | 0 |
| K221552 | EFAI ChestSuite XR Pneumothorax Assessment System | Ever Fortune.Ai, Co., Ltd. | 2022-11-08 | 161 | 0 |
| K222076 | EFAI ChestSuite XR Pleural Effusion Assessment System | Ever Fortune.Ai, Co., Ltd. | 2022-09-08 | 56 | 0 |
| K213731 | EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows | Ever Fortune.Ai, Co., Ltd. | 2022-05-31 | 186 | 0 |
| K220264 | EFAI RTSuite CT HN-Segmentation System | Ever Fortune.Ai, Co., Ltd. | 2022-04-28 | 87 | 0 |
| K212624 | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment Syst | Ever Fortune.Ai, Co., Ltd. | 2022-04-04 | 229 | 0 |
| K211257 | EFAI PACS Picture Archiving and Communication System | Ever Fortune.Ai, Co., Ltd. | 2021-09-10 | 137 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda