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12 devices · 5 companies · 2022 to 2026

Ever Fortune.Ai, Co., Ltd.: AI-enabled devices on FDA's list

12 devices from Ever Fortune.Ai, Co., Ltd., 2022 to 2026, from 5 companies across 4 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (12 of 12 here), the regulation, and MAUDE report counts by product code.

Retrieved from FDA public records.

Product codes from Ever Fortune.Ai, Co., Ltd.

Every device, newest decision first

Ever Fortune.Ai, Co., Ltd. · 12 devices
DecisionDevicePanelProduct codeFDA
EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEMK253163 · 510(k)RadiologyQASdatabase entry
Seg Pro V3K251306 · 510(k)RadiologyQKBdatabase entry
EFAI Chestsuite XR Malpositioned ETT AssessmentK242821 · 510(k)RadiologyQASdatabase entry
EFAI Neurosuite CT Midline Shift Assessment SystK241923 · 510(k)RadiologyQASdatabase entry
EFAI Bonesuite XR Bone Age Pro Assessment SystemK234042 · 510(k)RadiologyQIHdatabase entry
EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESK240291 · 510(k)RadiologyQASdatabase entry
EFAI NeuroSuite CT ICH Assessment SystemK231025 · 510(k)RadiologyQASdatabase entry
EFAI RTSUITE CT HCAP-Segmentation SystemK231928 · 510(k)RadiologyQKBdatabase entry
EFAI ChestSuite XR Pneumothorax Assessment SysteK221552 · 510(k)RadiologyQFMdatabase entry
EFAI ChestSuite XR Pleural Effusion Assessment SK222076 · 510(k)RadiologyQFMdatabase entry
EFAI RTSuite CT HN-Segmentation SystemK220264 · 510(k)RadiologyQKBdatabase entry
EFAI Intelligent Cardiothoracic RatioK212624 · 510(k)RadiologyQIHdatabase entry

Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.

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Every device here is authorized for a stated use. See a record read against what it must prove, on your own file.

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