EverFortune.AI Co., Ltd.

FDA Device Registration & Listing · TAICHUNG CITY, TW · Registration 3021032044

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3021032044
FEI Number
3021032044
Entity Name
EverFortune.AI Co., Ltd.
City/State/Country
TAICHUNG CITY, TW
Establishment Address
8F., No. 360, Sec. 1, Jingmao Rd., Beitun Dist., TAICHUNG CITY 406040, TW
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Ever Fortune.AI Co., Ltd. (Owner Number: 10083078)
Owner / Operator Contact Address
8F., No. 360, Sec. 1, Jingmao Rd., Beitun Dist., TAICHUNG CITY, TW-TXG 406040, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K220264
PMA Number
N/A

All Registered Proprietary Names

EFAI ChestSuite XR Pleural Effusion Assessment System EFAI Chestsuite XR Malpositioned ETT Assessment System EFAI PACS Picture Archiving and Communication System EFAI Bonesuite XR Bone Age Pro Assessment System EFAI Neurosuite CT Midline Shift Assessment System EFAI RTSUITE CT HCAP-Segmentation System EFAI RTSUITE CT HCAP-Segmentation System EFAI NeuroSuite CT ICH Assessment System Efai Pacs Picture Archiving and Communication System Pro EFAI RTSuite CT HN-Segmentation System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QFM Radiological Computer-Assisted Prioritization Software For Lesions Radiology Class 2 892.2080 2022-12-28
QAS Radiological Computer-Assisted Triage And Notification Software Radiology Class 2 892.2080 2025-03-10
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2021-10-24
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2024-11-14
QAS Radiological Computer-Assisted Triage And Notification Software Radiology Class 2 892.2080 2024-12-13
QKB Radiological Image Processing Software For Radiation Therapy Radiology Class 2 892.2050 2023-12-27
QAS Radiological Computer-Assisted Triage And Notification Software Radiology Class 2 892.2080 2024-11-14
QKB Radiological Image Processing Software For Radiation Therapy Radiology Class 2 892.2050 2026-02-05
QAS Radiological Computer-Assisted Triage And Notification Software Radiology Class 2 892.2080 2023-12-27
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2023-12-27
QKB Radiological Image Processing Software For Radiation Therapy Radiology Class 2 892.2050 2022-12-28

Official Correspondent

RA Dept. Ever Fortune.AI

US Agent Details

Diana Lin Email: dlin.realestate@gmail.com Phone: (213) 9496828

Related Public Records

Same Entity

Ever Fortune.AI Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K190362 Zebra Medical Vision, Ltd. HealthPNX 2019-05-06
K220709 Aidoc Medical , Ltd. BriefCase 2022-10-07
K080013 Agfa Healthcare Corporation REGISTRATION AND FUSION 2008-01-17
K042221 Barco NV Barcoview CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM 2004-12-30
K092915 Cedara Software Corp. CEDARA WEBACCESS, MODEL: 2.4 2010-06-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0012-2022 GE Healthcare, LLC 2
Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016 GE Healthcare 2
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026 CHANGE HEALTHCARE CANADA COMPANY 2
Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012 Philips Healthcare Inc. 2
MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007 AGFA Corp. 2
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

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3017604664 AVICENNA.AI La Ciotat Bouches-du-Rhone, FR
3017173128 CUREMETRIX, INC. San Diego, CA, US
3014678441 VIZ.AI, INC. Cary, NC, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021032044. Last updated year: 2026. Please use registration number 3021032044 when referencing this establishment in official correspondence.
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