FDA 510(k)

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

K号: K222191 · 2022-10-28

决定日期2022-10-28

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 2022-10-28 under 510(k) number K222191. 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 2022-10-28. The listed applicant is Supersonic Imagine. The 510(k) number is K222191.

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 2022-10-28, under 510(k) number K222191.

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 K203645Aixplorer MACH30/ 超声MACH30, Aixplorer MACH20/ 超声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

在 FDA 数据库中查看 →

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。