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FDA 510(k)

便携式肝脏弹性超声诊断系统（Liverscan Mobile）

K号: K233401 · 2024-02-12

申请人Eieling Technology Limited
决定日期2024-02-12
产品代码IYO
咨询委员会RA
决定实质等同

器械摘要

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) is the device name listed in this FDA 510(k) record. The listed applicant is Eieling Technology Limited. It received FDA 510(k) clearance on 2024-02-12 under 510(k) number K233401. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)?

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) is a medical device that received FDA 510(k) clearance on 2024-02-12. The listed applicant is Eieling Technology Limited. The 510(k) number is K233401.

When did Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) receive FDA 510(k) clearance?

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) received FDA 510(k) clearance on 2024-02-12, under 510(k) number K233401.

Who is the listed applicant for Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)?

The FDA 510(k) record lists Eieling Technology Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)?

The FDA product code for Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) is IYO.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：IYO）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260313MD-6000S 膀胱扫描仪MEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 型号 AQT Imaging Holdings, Inc.

官方来源

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