FDA 510(k)

Voluson™ 性能 16；Voluson™ 性能 18

K号: K250543 · 2025-05-29

申请人GE Medical Systems Ultrasound and Primary Care Diagnostics

决定日期2025-05-29

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Voluson™ Performance 16; Voluson™ Performance 18 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 2025-05-29 under 510(k) number K250543. 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 Voluson™ Performance 16; Voluson™ Performance 18?

Voluson™ Performance 16; Voluson™ Performance 18 is a medical device that received FDA 510(k) clearance on 2025-05-29. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K250543.

When did Voluson™ Performance 16; Voluson™ Performance 18 receive FDA 510(k) clearance?

Voluson™ Performance 16; Voluson™ Performance 18 received FDA 510(k) clearance on 2025-05-29, under 510(k) number K250543.

Who is the listed applicant for Voluson™ Performance 16; Voluson™ Performance 18?

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 Voluson™ Performance 16; Voluson™ Performance 18?

The FDA product code for Voluson™ Performance 16; Voluson™ Performance 18 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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