The Healthcare AI Institute / Transparency Registry
Transparency Registry · applicant

Ever Fortune.Ai, Co., Ltd.: 12 FDA AI clearances

Every 510(k) clearance held by Ever Fortune.Ai, Co., Ltd. under the AI-associated product codes this registry tracks, from openFDA public records, refreshed weekly. Facts only; listing is not evaluation.

DeviceDecision dateCategory
EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)2026-04-22QAS
Seg Pro V3 (RT-300)2026-01-28QKB
EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)2025-02-20QAS
EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)2024-12-06QAS
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)2024-06-07QIH
EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM2024-04-08QAS
EFAI NeuroSuite CT ICH Assessment System2023-10-04QAS
EFAI RTSUITE CT HCAP-Segmentation System2023-09-25QKB
EFAI ChestSuite XR Pneumothorax Assessment System2022-11-08QFM
EFAI ChestSuite XR Pleural Effusion Assessment System2022-09-08QFM
EFAI RTSuite CT HN-Segmentation System2022-04-28QKB
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System2022-04-04QIH

Sources linked on each entry. Coverage note: this lists clearances under tracked AI-associated codes only — the company may hold other clearances outside them. Work for Ever Fortune.Ai, Co., Ltd.? The disclosure rows on your entries update free on submission of public links — start here.

Link to this page. Many companies reference their registry listing from press pages and footers — it is a neutral, weekly-verified public record. Copy either snippet:

Text link:

Badge: