FDA-cleared K253163
EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)
Ever Fortune.Ai, Co., Ltd.
Triage notification of suspected appendicitis on contrast-enhanced abdominal CT
- Modality
- CT/CTA
- Anatomy
- Abdomen
- Decision
- 2026-04-22
Vendor
Ever Fortune.Ai, Co., Ltd.
12 FDA-cleared listings in this directory.
Claim vendor profile FDA-cleared K251306
Seg Pro V3 (RT-300)
Ever Fortune.Ai, Co., Ltd.
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...
- Modality
- Radiotherapy Planning Imaging
- Anatomy
- Head, neck, brain, thorax, abdomen, pelvis, and other labeled radiation-treatment regions
- Decision
- 2026-01-28
FDA-cleared K242821
EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
Ever Fortune.AI, Co., Ltd.
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...
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2025-02-20
FDA-cleared K241923
EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)
Ever Fortune.AI, Co., Ltd.
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
FDA-cleared K234042
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
Ever Fortune.AI Co., Ltd.
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...
- Modality
- X-ray/Radiography
- Anatomy
- Left hand and wrist / skeletal age
- Decision
- 2024-06-07
FDA-cleared K240291
EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM
Ever Fortune.AI, Co., Ltd.
Assist hospital networks and appropriately trained medical specialists in triaging adults aged 22 years and older by flagging suspected aortic dissection or aortic intramural...
- Modality
- CT/CTA
- Anatomy
- Chest, abdomen, and thoracoabdominal aorta
- Decision
- 2024-04-08
FDA-cleared K231025
EFAI NeuroSuite CT ICH Assessment System
Ever Fortune.AI Co., Ltd.
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...
- Modality
- CT/CTA
- Anatomy
- Brain/head
- Decision
- 2023-10-04
FDA-cleared K231928
EFAI RTSUITE CT HCAP-Segmentation System
Ever Fortune.AI Co., Ltd.
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...
- Modality
- Radiotherapy Planning Imaging
- Anatomy
- Adult organs at risk on non-contrast CT during radiation-treatment planning
- Decision
- 2023-09-25
FDA-cleared K221552
EFAI ChestSuite XR Pneumothorax Assessment System
Ever Fortune AI Co., Ltd.
EFAI PNXXR is a software workflow tool designed to aid the clinical assessment of adult (22 years of age or older). Posteroanterior (PA) view Chest X-Ray cases with features...
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2022-11-08
FDA-cleared K222076
EFAI ChestSuite XR Pleural Effusion Assessment System
Ever Fortune.AI Co., Ltd.
EFAI Chestsuite XR Pleural Effusion Assessment System is a software workflow tool designed to aid the clinical assessment of adult (18 years of age or older) Chest X-Ray cases...
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2022-09-08
FDA-cleared K220264
EFAI RTSuite CT HN-Segmentation System
Ever Fortune.AI Co., Ltd.
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...
- Modality
- Radiotherapy Planning Imaging
- Anatomy
- Head and neck organs at risk
- Decision
- 2022-04-28
FDA-cleared K212624
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
Ever Fortune. AI Co., Ltd.
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...
- Modality
- X-ray/Radiography
- Anatomy
- Heart and thoracic cavity for cardiothoracic-ratio measurement
- Decision
- 2022-04-04