Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Efai Pacs Picture Archiving and Communication System Pro

K-Number: K232100 · 2023-08-08

ApplicantEver Fortune.Ai, Co., Ltd.
Decision Date2023-08-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Efai Pacs Picture Archiving and Communication System Pro is a medical device manufactured by Ever Fortune.Ai, Co., Ltd.. It received FDA 510(k) clearance on 2023-08-08 under approval number K232100. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Efai Pacs Picture Archiving and Communication System Pro?

Efai Pacs Picture Archiving and Communication System Pro is a medical device that received FDA 510(k) clearance on 2023-08-08. It is manufactured by Ever Fortune.Ai, Co., Ltd.. The 510(k) number is K232100.

When was Efai Pacs Picture Archiving and Communication System Pro approved by the FDA?

Efai Pacs Picture Archiving and Communication System Pro received FDA 510(k) clearance on 2023-08-08, under approval number K232100.

What company makes Efai Pacs Picture Archiving and Communication System Pro?

Efai Pacs Picture Archiving and Communication System Pro is manufactured by Ever Fortune.Ai, Co., Ltd..

What is the FDA product code for Efai Pacs Picture Archiving and Communication System Pro?

The FDA product code for Efai Pacs Picture Archiving and Communication System Pro is LLZ.

Related Clinical Trials

NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT07557147 Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor NOT_YET_RECRUITING NCT07572253 A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial Fibrillation NOT_YET_RECRUITING NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING NCT07574229 Support System Design for Adolescent Scoliosis Orthosis Wear RECRUITING

Related PubMed Literature

PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

Other Devices by Ever Fortune.Ai, Co., Ltd.

K211257EFAI PACS Picture Archiving and Communication System K221552EFAI ChestSuite XR Pneumothorax Assessment System K222076EFAI ChestSuite XR Pleural Effusion Assessment System K213731EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows K220264EFAI RTSuite CT HN-Segmentation System K212624EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System

View all 15 devices →

Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑