FDA 510(k)

诊断型超声系统（Nano C5，Nano C5 EXP，Nano L12，和 Nano L12 EXP）

K号: K251268 · 2025-12-23

决定日期2025-12-23

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K251268. 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 Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)?

Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K251268.

When did Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) receive FDA 510(k) clearance?

Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) received FDA 510(k) clearance on 2025-12-23, under 510(k) number K251268.

Who is the listed applicant for Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)?

FDA 510(k)记录中列出Edan Instruments, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)?

The FDA product code for Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) is IYN.

列明Edan Instruments, Inc.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。

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查看所有 50 个设备 →

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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