FDA 510(k)

Versana Premier; Versana Premier Lotus; LOGIQ F

K号: K242005 · 2024-10-02

申请人GE Medical Systems Ultrasound and Primary Care Diagnostics

决定日期2024-10-02

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Versana Premier; Versana Premier Lotus; LOGIQ F 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 2024-10-02 under 510(k) number K242005. 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 Versana Premier; Versana Premier Lotus; LOGIQ F?

Versana Premier; Versana Premier Lotus; LOGIQ F is a medical device that received FDA 510(k) clearance on 2024-10-02. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K242005.

When did Versana Premier; Versana Premier Lotus; LOGIQ F receive FDA 510(k) clearance?

Versana Premier; Versana Premier Lotus; LOGIQ F received FDA 510(k) clearance on 2024-10-02, under 510(k) number K242005.

Who is the listed applicant for Versana Premier; Versana Premier Lotus; LOGIQ F?

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 Versana Premier; Versana Premier Lotus; LOGIQ F?

The FDA product code for Versana Premier; Versana Premier Lotus; LOGIQ F 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软件仅用 / EchoPAC插件（v211）K261313Vivid 探索者/Vivid 高级/Vivid 焦点 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

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

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