FDA 510(k)

Rapid MLS

K号: K243378 · 2025-05-28

决定日期2025-05-28

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

Rapid MLS is the device name listed in this FDA 510(k) record. The listed applicant is Ischemaview, Inc.. It received FDA 510(k) clearance on 2025-05-28 under 510(k) number K243378. 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 Rapid MLS?

Rapid MLS is a medical device that received FDA 510(k) clearance on 2025-05-28. The listed applicant is Ischemaview, Inc.. The 510(k) number is K243378.

When did Rapid MLS receive FDA 510(k) clearance?

Rapid MLS received FDA 510(k) clearance on 2025-05-28, under 510(k) number K243378.

Who is the listed applicant for Rapid MLS?

FDA 510(k)记录中列出Ischemaview，Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Rapid MLS?

The FDA product code for Rapid MLS is QIH.

列明Ischemaview, 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。

K261368快速平台（R6.7）K251987Rapid 主动脉测量 K251533Rapid 阻塞性脑积水，Rapid OH K252526Rapid DeltaFuse K243350Rapid Neuro3D K233582Rapid

查看所有 21 个设备 →

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。