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FDA 510(k)

X3 Exp/X3/X3 Pro/X1 Pro/X1 数字彩色多普勒超声系统

K号: K163427 · 2017-01-03

决定日期2017-01-03
产品代码IYN
咨询委员会RA
决定实质等同

器械摘要

X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Sonoscape Medical Corp.. It received FDA 510(k) clearance on 2017-01-03 under 510(k) number K163427. 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 X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System?

X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System is a medical device that received FDA 510(k) clearance on 2017-01-03. The listed applicant is Sonoscape Medical Corp.. The 510(k) number is K163427.

When did X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System receive FDA 510(k) clearance?

X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System received FDA 510(k) clearance on 2017-01-03, under 510(k) number K163427.

Who is the listed applicant for X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System?

FDA 510(k)记录将Sonoscape Medical Corp.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System?

The FDA product code for X3 Exp/X3/X3 Pro/X1 Pro/X1 Digital Color Doppler Ultrasound System is IYN.

相关临床试验

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。

列明Sonoscape Medical Corp.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。

官方来源

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