Company profile

Ever Fortune.Ai, Co., Ltd.

Ever Fortune.Ai, Co., Ltd. has 10 AI-enabled medical devices on the FDA list. The first decision was on April 28, 2022 and the most recent on April 22, 2026 (EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)). Its most common review panel is Radiology (10 devices).

10AI devices

2022First decision

2026Latest decision

1Specialties

Per year

20222023202420252026

Ever Fortune.Ai, Co., Ltd. AI devices per year: 2022 2, 2023 2, 2024 3, 2025 1, 2026 2

By specialty

Radiology10

Related guides

Top radiology devices

Timeline

April 22, 2026 · 510(k) K253163EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) · Radiology · QAS
January 28, 2026 · 510(k) K251306Seg Pro V3 (RT-300) · Radiology · QKB
February 20, 2025 · 510(k) K242821EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) · Radiology · QAS
December 6, 2024 · 510(k) K241923EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) · Radiology · QAS
June 7, 2024 · 510(k) K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) · Radiology · QIH
April 8, 2024 · 510(k) K240291EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM · Radiology · QAS
October 4, 2023 · 510(k) K231025EFAI NeuroSuite CT ICH Assessment System · Radiology · QAS
September 25, 2023 · 510(k) K231928EFAI RTSUITE CT HCAP-Segmentation System · Radiology · QKB
September 8, 2022 · 510(k) K222076EFAI ChestSuite XR Pleural Effusion Assessment System · Radiology · QFM
April 28, 2022 · 510(k) K220264EFAI RTSuite CT HN-Segmentation System · Radiology · QKB