FDA 510(k)

便携式肝脏弹性超声诊断系统（Liverscan C）

K号: K242496 · 2024-11-19

申请人Eieling Technology (Shenzhen) Limited

决定日期2024-11-19

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 C) is the device name listed in this FDA 510(k) record. The listed applicant is Eieling Technology (Shenzhen) Limited. It received FDA 510(k) clearance on 2024-11-19 under 510(k) number K242496. 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 C)?

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) is a medical device that received FDA 510(k) clearance on 2024-11-19. The listed applicant is Eieling Technology (Shenzhen) Limited. The 510(k) number is K242496.

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

Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) received FDA 510(k) clearance on 2024-11-19, under 510(k) number K242496.

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

The FDA 510(k) record lists Eieling Technology (Shenzhen) 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 C)?

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

列明Eieling Technology (Shenzhen) Limited为申报人的其他记录

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。

K253221肝脂肪超声定量系统，The FattaLab (FL-CC M1, FL-CC M1_Pro)

官方来源

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