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EverFortune.AI Co., Ltd.: FDA-registered device maker in Taichung City, Taiwan, 14 510(k) clearances

EverFortune.AI Co., Ltd. is registered with the FDA (registration 3021032044) in Taichung City, Taiwan. It lists 6 device types. The FDA files 14 510(k) clearances under its listings, the newest dated January 28, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3021032044
Address
8F., No. 360, Sec. 1, Jingmao Rd., Beitun Dist., Taichung City, Taiwan, 406040
Owner or operator
Ever Fortune.AI Co., Ltd. (10083078)
Roles
Manufacturer
First device listed
October 24, 2021
Registered through
2026
Brand names listed
EFAI Bonesuite XR Bone Age Pro Assessment System, EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows, EFAI ChestSuite XR Pleural Effusion Assessment System, EFAI ChestSuite XR Pneumothorax Assessment System, EFAI Chestsuite XR Malpositioned ETT Assessment System, EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System, EFAI NeuroSuite CT ICH Assessment System, EFAI Neurosuite CT Midline Shift Assessment System and more

Devices it lists

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 28, 2026K251306Seg Pro V3 (RT-300)QKBSubstantially EquivalentEver Fortune.Ai, Co., Ltd.accessdata.fda.gov
February 20, 2025K242821EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)QASSubstantially EquivalentEver Fortune.Ai, Co., Ltd.accessdata.fda.gov
December 6, 2024K241923EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)QASSubstantially EquivalentEver Fortune.Ai, Co., Ltd.accessdata.fda.gov
June 7, 2024K234042EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)QIHSubstantially EquivalentEver Fortune.Ai, Co., Ltd.accessdata.fda.gov
April 8, 2024K240291EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEMQASSubstantially EquivalentEver Fortune.Ai, Co., Ltd.accessdata.fda.gov
October 4, 2023K231025EFAI NeuroSuite CT ICH Assessment SystemQASSubstantially EquivalentEver Fortune.Ai, Co., Ltd.accessdata.fda.gov
September 25, 2023K231928EFAI RTSUITE CT HCAP-Segmentation SystemQKBSubstantially EquivalentEver Fortune.Ai, Co., Ltd.accessdata.fda.gov
August 8, 2023K232100Efai Pacs Picture Archiving and Communication System ProLLZSubstantially EquivalentEver Fortune.Ai, Co., Ltd.accessdata.fda.gov
November 8, 2022K221552EFAI ChestSuite XR Pneumothorax Assessment SystemQFMSubstantially EquivalentEver Fortune.Ai, Co., Ltd.accessdata.fda.gov
September 8, 2022K222076EFAI ChestSuite XR Pleural Effusion Assessment SystemQFMSubstantially EquivalentEver Fortune.Ai, Co., Ltd.accessdata.fda.gov
May 31, 2022K213731EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile WorkflowsKPSSubstantially EquivalentEver Fortune.Ai, Co., Ltd.accessdata.fda.gov
April 28, 2022K220264EFAI RTSuite CT HN-Segmentation SystemQKBSubstantially EquivalentEver Fortune.Ai, Co., Ltd.accessdata.fda.gov
April 4, 2022K212624EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemQIHSubstantially EquivalentEver Fortune.Ai, Co., Ltd.accessdata.fda.gov
September 10, 2021K211257EFAI PACS Picture Archiving and Communication SystemLLZSubstantially EquivalentEver Fortune.Ai, Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated January 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.