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Ever Fortune.Ai, Co., Ltd.

TaiwanFDA 510(k) applicant, unverified FDA

Devices
15
Registrations
FDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA establishment

What Ever Fortune.Ai, Co., Ltd. makes

Ever Fortune.Ai, Co., Ltd. develops AI-powered diagnostic systems for radiology and medical imaging, including automated assessment tools for intracranial hemorrhage (CT ICH), aortic syndromes (CTA), pleural effusion, pneumothorax, and appendicitis. Their portfolio also covers specialized X-ray analysis for endotracheal tube (ETT) positioning, bone age estimation, and midline shift detection in CT scans. Additional offerings include a picture archiving and communication system (PACS) for medical imaging storage and retrieval, as well as segmentation tools for hospital-acquired pneumonia (HCAP) detection in CT imaging.

The company’s devices are classified as Class II under FDA regulations and are tracked through 510(k) premarket notifications. These products are intended for use in the United States, where the manufacturer is based.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue15

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FDA establishments1

Registered with the FDA under this company group, matched by name.

  • EverFortune.AI Co., Ltd. TAICHUNG CITY · TW FEI 3021032044

Frequently asked questions

How many devices does Ever Fortune.Ai, Co., Ltd. have in the registry?

The registry currently lists 15 devices for Ever Fortune.Ai, Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Ever Fortune.Ai, Co., Ltd.'s devices?

Among its 15 most recently registered devices, Ever Fortune.Ai, Co., Ltd. has devices listed in FDA 510(k) (15 devices).

What risk classes do Ever Fortune.Ai, Co., Ltd.'s devices fall under?

Among its 15 most recently registered devices, the classes recorded for Ever Fortune.Ai, Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Ever Fortune.Ai, Co., Ltd. in the registry?

The most recently registered devices listed for Ever Fortune.Ai, Co., Ltd. include EFAI NeuroSuite CT ICH Assessment System, Seg Pro V3 (RT-300), EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System and EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM.

Which FDA establishments are linked to Ever Fortune.Ai, Co., Ltd.?

1 FDA establishment is linked to Ever Fortune.Ai, Co., Ltd. in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.