FDA 510(k)

InnerView 系统

K号: K251597 · 2025-09-18

决定日期2025-09-18

产品代码EKX

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决定实质等同

器械摘要

InnerView System is the device name listed in this FDA 510(k) record. The listed applicant is Perimetrics, Inc.. It received FDA 510(k) clearance on 2025-09-18 under 510(k) number K251597. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the InnerView System?

InnerView System is a medical device that received FDA 510(k) clearance on 2025-09-18. The listed applicant is Perimetrics, Inc.. The 510(k) number is K251597.

When did InnerView System receive FDA 510(k) clearance?

InnerView System received FDA 510(k) clearance on 2025-09-18, under 510(k) number K251597.

Who is the listed applicant for InnerView System?

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

What is the FDA product code for InnerView System?

The FDA product code for InnerView System is EKX.

列明Perimetrics, 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。

K232657InnerView LC

官方来源

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