FDA 510(k)

Aquilion Lightning, TSX-036A/1, V8.4

K号: K170019 · 2017-02-02

决定日期2017-02-02

产品代码JAK

咨询委员会RA

决定实质等同

器械摘要

Aquilion Lightning, TSX-036A/1, V8.4 is the device name listed in this FDA 510(k) record. The listed applicant is Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2017-02-02 under 510(k) number K170019. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Aquilion Lightning, TSX-036A/1, V8.4?

Aquilion Lightning, TSX-036A/1, V8.4 is a medical device that received FDA 510(k) clearance on 2017-02-02. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K170019.

When did Aquilion Lightning, TSX-036A/1, V8.4 receive FDA 510(k) clearance?

Aquilion Lightning, TSX-036A/1, V8.4 received FDA 510(k) clearance on 2017-02-02, under 510(k) number K170019.

Who is the listed applicant for Aquilion Lightning, TSX-036A/1, V8.4?

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

What is the FDA product code for Aquilion Lightning, TSX-036A/1, V8.4?

The FDA product code for Aquilion Lightning, TSX-036A/1, V8.4 is JAK.

列明Toshibamedical Systems Corporation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。

K173962Viamo c100 TUS-VC100 诊断超声系统 K173468Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 K173088Vitrea软件东芝包VSTP-001A K173382Vantage Galan 3T，V4.6 K173090Aplio i900/i800/i700/i600 诊断超声系统，V2.4 K172863Infinix-i, INFX-8000V, V7.0

查看所有 27 个设备 →

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。