Ever Fortune.Ai, Co., Ltd. radiology AI products

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Radiology AI pricing and total cost of ownership

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FDA-cleared K253163

EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)

Ever Fortune.Ai, Co., Ltd.

Authorized purpose: Triage notification of suspected appendicitis on contrast-enhanced abdominal CT

Modality: CT/CTA
Anatomy: Abdomen
Decision: 2026-04-22

Acute triage and notification

FDA-cleared K251306

Seg Pro V3 (RT-300)

Ever Fortune.Ai, Co., Ltd.

Authorized purpose: Seg Pro V3 generates initial organ-at-risk contours on DICOM images for radiation-treatment planning by radiation oncologists, medical physicists, and dosimetrists; the contours require professional review and editing.

Modality: Radiotherapy Planning Imaging
Anatomy: Head, neck, brain, thorax, abdomen, pelvis, and other labeled radiation-treatment regions
Decision: 2026-01-28

Radiotherapy planning

FDA-cleared K242821

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

Ever Fortune.AI, Co., Ltd.

Authorized purpose: Passive triage of adult AP chest radiographs for an endotracheal-tube tip more than 7 cm above the carina, less than 3 cm above the carina, below the carina in the right or left mainstem, or other listed malposition states.

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2025-02-20

Acute triage and notification

FDA-cleared K241923

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

Ever Fortune.AI, Co., Ltd.

Authorized purpose: Prioritization and triage of non-contrast head CT cases with features suggestive of midline shift in individuals aged 18 years and older.

Modality: CT/CTA
Anatomy: Head/brain, for suspected midline shift (MLS)
Decision: 2024-12-06

Acute triage and notification

FDA-cleared K234042

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

Ever Fortune.AI Co., Ltd.

Authorized purpose: Aid pediatric radiologists in assessing bone age from PA left-hand radiographs for patients aged 2-16 years; the result is an adjunct and must not be used alone for diagnostic decisions.

Modality: X-ray/Radiography
Anatomy: Left hand and wrist / skeletal age
Decision: 2024-06-07

MSK and bone

FDA-cleared K240291

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

Ever Fortune.AI, Co., Ltd.

Authorized purpose: Assist hospital networks and appropriately trained medical specialists in triaging adults aged 22 years and older by flagging suspected aortic dissection or aortic intramural hematoma on chest or chest-abdomen CTA.

Modality: CT/CTA
Anatomy: Chest, abdomen, and thoracoabdominal aorta
Decision: 2024-04-08

CT/CTA workflow

FDA-cleared K231025

EFAI NeuroSuite CT ICH Assessment System

Ever Fortune.AI Co., Ltd.

Authorized purpose: Case-level prioritization and passive notification for adult non-contrast head CT studies with features suggestive of acute intracranial hemorrhage (ICH); not a stand-alone diagnostic or rule-out tool.

Modality: CT/CTA
Anatomy: Brain/head
Decision: 2023-10-04

Stroke and ICH triage Acute triage and notification

FDA-cleared K231928

EFAI RTSUITE CT HCAP-Segmentation System

Ever Fortune.AI Co., Ltd.

Authorized purpose: EFAI HCAPSeg assists trained radiation-oncology professionals with radiation-treatment planning by providing initial deep-learning contours of organs at risk on non-contrast CT images for transfer to a DICOM-compliant treatment-planning system.

Modality: Radiotherapy Planning Imaging
Anatomy: Adult organs at risk on non-contrast CT during radiation-treatment planning
Decision: 2023-09-25

Radiotherapy planning Oncology quantification

FDA-cleared K221552

EFAI ChestSuite XR Pneumothorax Assessment System

Ever Fortune AI Co., Ltd.

Authorized purpose: Passive PACS/worklist prioritization for suspected pneumothorax in adult PA chest X-rays.

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2022-11-08

Acute triage and notification

FDA-cleared K222076

EFAI ChestSuite XR Pleural Effusion Assessment System

Ever Fortune.AI Co., Ltd.

Authorized purpose: Passive triage notification for adult chest X-ray cases suggestive of pleural effusion.

Modality: X-ray/Radiography
Anatomy: Chest
Decision: 2022-09-08

Acute triage and notification

FDA-cleared K220264

EFAI RTSuite CT HN-Segmentation System

Ever Fortune.AI Co., Ltd.

Authorized purpose: EFAI RTSuite CT HN-Segmentation System automatically delineates head-and-neck organs at risk on adult non-contrast CT images to support radiation-treatment workflows; initial contours are transferred to a DICOM-compliant treatment-planning system for professional review and editing.

Modality: Radiotherapy Planning Imaging
Anatomy: Head and neck organs at risk
Decision: 2022-04-28

Radiotherapy planning Quantification and segmentation

FDA-cleared K212624

EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System

Ever Fortune. AI Co., Ltd.

Authorized purpose: Automatic cardiothoracic-ratio assessment on PA chest X-ray images for adults 20-80 years old in healthcare institutions; results support clinician assessment and are not for standalone clinical decision-making.

Modality: X-ray/Radiography
Anatomy: Heart and thoracic cavity for cardiothoracic-ratio measurement
Decision: 2022-04-04

Cardiac imaging Quantification and segmentation