Chrysalis Intelligence · Sponsors · Ever Fortune.Ai, Co., Ltd.

Ever Fortune.Ai, Co., Ltd.

Taichung City, TW · 15 510(k) clearances

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Total clearances
15
2021-09-10 → 2026-04-22
Last 12 months
2
Product codes
6
Most recent
2026-04-22
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QAS Radiological Computer-Assisted Triage And Notification Software Class II Radiology 5 2026-04-22
QKB Radiological Image Processing Software For Radiation Therapy Class II Radiology 3 2026-01-28
QIH Automated Radiological Image Processing Software Class II Radiology 2 2024-06-07
LLZ System, Image Processing, Radiological Class II Radiology 2 2023-08-08
QFM Radiological Computer-Assisted Prioritization Software For Lesions Class II Radiology 2 2022-11-08
KPS System, Tomography, Computed, Emission Class II Radiology 1 2022-05-31
Filings

All 510(k) clearances (15)

Date K-number Device Code Class Specialty
2026-04-22 K253163 EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) QAS Class II Radiology
2026-01-28 K251306 Seg Pro V3 (RT-300) QKB Class II Radiology
2025-02-20 K242821 EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) QAS Class II Radiology
2024-12-06 K241923 EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) QAS Class II Radiology
2024-06-07 K234042 EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) QIH Class II Radiology
2024-04-08 K240291 EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM QAS Class II Radiology
2023-10-04 K231025 EFAI NeuroSuite CT ICH Assessment System QAS Class II Radiology
2023-09-25 K231928 EFAI RTSUITE CT HCAP-Segmentation System QKB Class II Radiology
2023-08-08 K232100 Efai Pacs Picture Archiving and Communication System Pro LLZ Class II Radiology
2022-11-08 K221552 EFAI ChestSuite XR Pneumothorax Assessment System QFM Class II Radiology
2022-09-08 K222076 EFAI ChestSuite XR Pleural Effusion Assessment System QFM Class II Radiology
2022-05-31 K213731 EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows KPS Class II Radiology
2022-04-28 K220264 EFAI RTSuite CT HN-Segmentation System QKB Class II Radiology
2022-04-04 K212624 EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System QIH Class II Radiology
2021-09-10 K211257 EFAI PACS Picture Archiving and Communication System LLZ Class II Radiology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence