FDA 510(k)

LOGIQ E9, LOGIQ E9 XDClear 2.0

K号: K163077 · 2016-11-17

申请人GE Medical Systems Ultrasound and Primary Care Diagnostics

决定日期2016-11-17

产品代码IYN

咨询委员会RA

决定Substantially Equivalent

器械摘要

LOGIQ E9, LOGIQ E9 XDClear 2.0 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 2016-11-17 under 510(k) number K163077. 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 LOGIQ E9, LOGIQ E9 XDClear 2.0?

LOGIQ E9, LOGIQ E9 XDClear 2.0 is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K163077.

When did LOGIQ E9, LOGIQ E9 XDClear 2.0 receive FDA 510(k) clearance?

LOGIQ E9, LOGIQ E9 XDClear 2.0 received FDA 510(k) clearance on 2016-11-17, under 510(k) number K163077.

Who is the listed applicant for LOGIQ E9, LOGIQ E9 XDClear 2.0?

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 LOGIQ E9, LOGIQ E9 XDClear 2.0?

The FDA product code for LOGIQ E9, LOGIQ E9 XDClear 2.0 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)K261313Vivid Explorer/Vivid Advanced/Vivid Focus 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

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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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