# Ever Fortune.Ai, Co., Ltd.

- Location (FDA's records): Taichung City, TW
- FDA decisions: 15 (2021–2026): 15 510(k) clearances
- Product codes: QAS (5), QKB (3), QFM (2), QIH (2), LLZ (2), KPS (1)
- 510(k) review time since 2016: median 158 days, against 121 for FDA's reviews in the same codes and years (5 of 15 faster)
- Predicates its devices cite: 15 (3 its own); citations of its devices by later devices: 7 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Aidoc Medical, Ltd.: 3 (https://510kreport.com/company/aidoc-medical)
- Adac Laboratories: 1 (https://510kreport.com/company/adac-laboratories)
- Behold.Ai Technologies Limited: 1 (https://510kreport.com/company/behold-ai-technologies)
- Imbio, LLC: 1 (https://510kreport.com/company/imbio)
- Curacloud Corp.: 1 (https://510kreport.com/company/curacloud)
- Qure.Ai Technologies: 1 (https://510kreport.com/company/qure-ai-technologies)
- Arterys, Inc.: 1 (https://510kreport.com/company/arterys)
- Xiamen Manteia Technology, Ltd.: 1 (https://510kreport.com/company/xiamen-manteia-technology)

## Firms that cite its devices most
- Innolitics, LLC: 1 (https://510kreport.com/company/innolitics)
- Qure.Ai Technologies: 1 (https://510kreport.com/company/qure-ai-technologies)
- Crescom Co., Ltd.: 1 (https://510kreport.com/company/crescom)
- Visiana: 1 (https://510kreport.com/company/visiana)

## Its most-cited devices
- K212624: EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System (2022), cited by 2
- K234042: EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) (2024), cited by 2
- K231928: EFAI RTSUITE CT HCAP-Segmentation System (2023), cited by 1
- K211257: EFAI PACS Picture Archiving and Communication System (2021), cited by 1
- K220264: EFAI RTSuite CT HN-Segmentation System (2022), cited by 1

## Recent decisions
- K253163: Efai Ersuite CT Appendicitis Assessment System (Appen-CT-100) (Apr 22, 2026)
- K251306: Seg Pro V3 (RT-300) (Jan 28, 2026)
- K242821: EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) (Feb 20, 2025)
- K241923: EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) (Dec 6, 2024)
- K234042: EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) (Jun 7, 2024)
- K240291: Efai Cardiosuite Cta Acute Aortic Syndrome Assessment System (Apr 8, 2024)
- K231025: EFAI NeuroSuite CT ICH Assessment System (Oct 4, 2023)
- K231928: EFAI RTSUITE CT HCAP-Segmentation System (Sep 25, 2023)

Source page: https://510kreport.com/company/ever-fortune-ai