Ever Fortune.Ai, Co., Ltd. - FDA 510(k) Cleared Devices

Cleared Jan 28, 2026

Seg Pro V3 (RT-300)

K251306 · QKB

Radiology · 275d

Cleared Feb 20, 2025

EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)

K242821 · QAS

Radiology · 155d

Cleared Dec 06, 2024

EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)

K241923 · QAS

Radiology · 158d

Cleared Jun 07, 2024

EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)

K234042 · QIH

Radiology · 169d

Cleared Apr 08, 2024

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

K240291 · QAS

Radiology · 67d

Cleared Oct 04, 2023

EFAI NeuroSuite CT ICH Assessment System

K231025 · QAS

Radiology · 176d

Cleared Sep 25, 2023

EFAI RTSUITE CT HCAP-Segmentation System

K231928 · QKB

Radiology · 87d

Cleared Aug 08, 2023

Efai Pacs Picture Archiving and Communication System Pro

K232100 · LLZ

Radiology · 25d

Cleared Nov 08, 2022

EFAI ChestSuite XR Pneumothorax Assessment System

K221552 · QFM

Radiology · 161d

Cleared Sep 08, 2022

EFAI ChestSuite XR Pleural Effusion Assessment System

K222076 · QFM

Radiology · 56d

Cleared May 31, 2022

EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows

K213731 · KPS

Radiology · 186d

Cleared Apr 28, 2022

EFAI RTSuite CT HN-Segmentation System

K220264 · QKB

Radiology · 87d