FDA 510(k)

Lumify 诊断超声系统

K号: K232500 · 2023-10-26

决定日期2023-10-26

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Lumify Diagnostic Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Philips Ultrasound. It received FDA 510(k) clearance on 2023-10-26 under 510(k) number K232500. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Lumify Diagnostic Ultrasound System?

Lumify Diagnostic Ultrasound System is a medical device that received FDA 510(k) clearance on 2023-10-26. The listed applicant is Philips Ultrasound. The 510(k) number is K232500.

When did Lumify Diagnostic Ultrasound System receive FDA 510(k) clearance?

Lumify Diagnostic Ultrasound System received FDA 510(k) clearance on 2023-10-26, under 510(k) number K232500.

Who is the listed applicant for Lumify Diagnostic Ultrasound System?

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

What is the FDA product code for Lumify Diagnostic Ultrasound System?

The FDA product code for Lumify Diagnostic Ultrasound System is IYN.

列明Philips Ultrasound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。

K242519Lumify 诊断超声系统 K242670Lumify 诊断超声系统 K223771Lumify 诊断超声系统

相关器械（代码：IYN）

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。

官方来源

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