FDA-cleared K212624
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
Ever Fortune. AI Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2022-04-04
Vendor
Ever Fortune. AI Co., Ltd.
10 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K220264
EFAI RTSuite CT HN-Segmentation System
Ever Fortune.AI Co., Ltd.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2022-04-28
FDA-cleared K222076
EFAI ChestSuite XR Pleural Effusion Assessment System
Ever Fortune.AI Co., Ltd.
Image analysis/processing for Chest/Lung using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2022-09-08
FDA-cleared K221552
EFAI ChestSuite XR Pneumothorax Assessment System
Ever Fortune AI Co., Ltd.
Image analysis/processing for Chest/Lung using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Chest/Lung
- Decision
- 2022-11-08
FDA-cleared K231928
EFAI RTSUITE CT HCAP-Segmentation System
Ever Fortune.AI Co., Ltd.
Image analysis/processing.
- Modality
- Radiotherapy planning imaging
- Anatomy
- N/A
- Decision
- 2023-09-25
FDA-cleared K231025
EFAI NeuroSuite CT ICH Assessment System
Ever Fortune.AI Co., Ltd.
Image analysis/processing for Brain using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Brain
- Decision
- 2023-10-04
FDA-cleared K240291
EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM
Ever Fortune.AI, Co., Ltd.
Image analysis/processing for Cardiovascular using CT/CTA.
- Modality
- CT/CTA
- Anatomy
- Cardiovascular
- Decision
- 2024-04-08
FDA-cleared K234042
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
Ever Fortune.AI Co., Ltd.
Image analysis/processing for Bone using X-ray/Radiography.
- Modality
- X-ray/Radiography
- Anatomy
- Bone
- Decision
- 2024-06-07
FDA-cleared K241923
EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)
Ever Fortune.AI, Co., Ltd.
Image analysis/processing.
- Modality
- CT/CTA
- Anatomy
- N/A
- Decision
- 2024-12-06
FDA-cleared K242821
EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
Ever Fortune.AI, Co., Ltd.
Image analysis/processing.
- Modality
- X-ray/Radiography
- Anatomy
- N/A
- Decision
- 2025-02-20