FDA 510(k)

Vivid T9/Vivid T8

K号: K243628 · 2025-02-11

申请人GE Medical Systems Ultrasound and Primary Care Diagnostics

决定日期2025-02-11

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Vivid T9/Vivid T8 is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2025-02-11 under 510(k) number K243628. 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 Vivid T9/Vivid T8?

Vivid T9/Vivid T8 is a medical device that received FDA 510(k) clearance on 2025-02-11. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K243628.

When did Vivid T9/Vivid T8 receive FDA 510(k) clearance?

Vivid T9/Vivid T8 received FDA 510(k) clearance on 2025-02-11, under 510(k) number K243628.

Who is the listed applicant for Vivid T9/Vivid T8?

FDA 510(k)记录将GE医疗系统超声和初级护理诊断列为申请人。这本身并不足以确立设备制造商。

What is the FDA product code for Vivid T9/Vivid T8?

The FDA product code for Vivid T9/Vivid T8 is IYN.

列明GE Medical Systems Ultrasound and Primary Care Diagnostics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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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。

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