FDA 510(k)

Vivid Explorer/Vivid Advanced/Vivid Focus

K号: K261313 · 2026-09-02

申请人GE Medical Systems Ultrasound and Primary Care Diagnostics

决定日期2026-09-02

产品代码IYN

咨询委员会RA

决定Substantially Equivalent

器械摘要

Vivid Explorer/Vivid Advanced/Vivid Focus 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 2026-09-02 under 510(k) number K261313. 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 Explorer/Vivid Advanced/Vivid Focus?

Vivid Explorer/Vivid Advanced/Vivid Focus is a medical device that received FDA 510(k) clearance on 2026-09-02. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K261313.

When did Vivid Explorer/Vivid Advanced/Vivid Focus receive FDA 510(k) clearance?

Vivid Explorer/Vivid Advanced/Vivid Focus received FDA 510(k) clearance on 2026-09-02, under 510(k) number K261313.

Who is the listed applicant for Vivid Explorer/Vivid Advanced/Vivid Focus?

The FDA 510(k) record lists GE Medical Systems Ultrasound and Primary Care Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vivid Explorer/Vivid Advanced/Vivid Focus?

The FDA product code for Vivid Explorer/Vivid Advanced/Vivid Focus 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。

K261623EchoPAC Software Only / EchoPAC Plug-in (v211)K261835LOGIQ Focus K260398LOGIQ e K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power K253370LOGIQ Totus K253366LOGIQ Fortis

查看所有 65 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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。