FDA 510(k)

Aixplorer MACH30/ 超声MACH30, Aixplorer MACH20/ 超声MACH20, 超声MACH40

K号: K203645 · 2021-06-29

决定日期2021-06-29

产品代码IYN

咨询委员会RA

决定实质等同

器械摘要

Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40 is the device name listed in this FDA 510(k) record. The listed applicant is Supersonic Imagine. It received FDA 510(k) clearance on 2021-06-29 under 510(k) number K203645. 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 Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40?

Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40 is a medical device that received FDA 510(k) clearance on 2021-06-29. The listed applicant is Supersonic Imagine. The 510(k) number is K203645.

When did Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40 receive FDA 510(k) clearance?

Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40 received FDA 510(k) clearance on 2021-06-29, under 510(k) number K203645.

Who is the listed applicant for Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40?

The FDA 510(k) record lists Supersonic Imagine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40?

The FDA product code for Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40 is IYN.

列明Supersonic Imagine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。

K242223SuperSonic HepaVu K222191Aixplorer MACH30 / 超声MACH30, Aixplorer MACH20 / 超声MACH20, MACH20, 超声MACH40 K202455Aixplorer®MACH20, Aixplorer®MACH30, 超声MACH40, 超声MACH30 & 超声MACH20超声诊断系统 K191007Aixplorer MACH 30, Aixplorer MACH 20超声诊断系统 K180572AIXPLORER MACH 超声诊断系统 Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 K173021Aixplorer & Aixplorer Ultimate超声诊断系统

查看所有 9 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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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。