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.

Is this your company? This profile is built from public FDA records and read by hospital governance and procurement teams verifying clearances. Vendors can add public disclosure links to their entries free of charge, a verified profile adds your website, governance contact and sealed governance record to this page, and the vendor resources page covers what buyers now ask for in diligence. Corrections: hello@healthcareaiops.com.
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.

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