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FDA 510(k)

Viz RV/LV

K号: K221100 · 2022-08-29

申请人Viz. Ai, Inc.
决定日期2022-08-29
产品代码QIH
咨询委员会RA
决定实质等同

器械摘要

Viz RV/LV is the device name listed in this FDA 510(k) record. The listed applicant is Viz. Ai, Inc.. It received FDA 510(k) clearance on 2022-08-29 under 510(k) number K221100. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Viz RV/LV?

Viz RV/LV is a medical device that received FDA 510(k) clearance on 2022-08-29. The listed applicant is Viz. Ai, Inc.. The 510(k) number is K221100.

When did Viz RV/LV receive FDA 510(k) clearance?

Viz RV/LV received FDA 510(k) clearance on 2022-08-29, under 510(k) number K221100.

Who is the listed applicant for Viz RV/LV?

The FDA 510(k) record lists Viz. Ai, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Viz RV/LV?

The FDA product code for Viz RV/LV is QIH.

列明Viz. Ai, Inc.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。

K250354Viz Subdural+，Viz SUBDURAL PLUSK232363Viz HDS，Viz Volume Plus，Viz ICH+K223443Viz AAAK223042Viz LVO ContaCTK220439Viz SDHK213319Viz 脑动脉瘤，Viz 焦虑

查看所有 10 个设备 →

相关器械（代码：QIH）

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。

K260055syngo.CT 脑部量化Siemens Medical Solutions USA, Inc.K262390骨专家VisianaK261368快速平台（R6.7）Ischemaview, Inc.K261623EchoPAC软件仅用 / EchoPAC插件（v211）GE Medical Systems Ultrasound and Primary Care DiagnosticsK261677人工智能肾脏评估（AIRA）版本 1Aramis Global AI Consultancies, LLCK2608794DMINVIA, LLC

官方来源

在 FDA 数据库中查看 →

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