FDA 510(k)

SMART PCFD

K号: K250023 · 2025-09-29

决定日期2025-09-29

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

SMART PCFD is the device name listed in this FDA 510(k) record. The listed applicant is Disior, Ltd.. It received FDA 510(k) clearance on 2025-09-29 under 510(k) number K250023. 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 SMART PCFD?

SMART PCFD is a medical device that received FDA 510(k) clearance on 2025-09-29. The listed applicant is Disior, Ltd.. The 510(k) number is K250023.

When did SMART PCFD receive FDA 510(k) clearance?

SMART PCFD received FDA 510(k) clearance on 2025-09-29, under 510(k) number K250023.

Who is the listed applicant for SMART PCFD?

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

What is the FDA product code for SMART PCFD?

The FDA product code for SMART PCFD is QIH.

列明Disior, Ltd.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。

K253764ENOS 软件引导的外固定系统 K240736SMART Bun-Yo-Matic X-Ray K240642SMART Bun-Yo-Matic CT K223757Bonelogic K203290Bonelogic

官方来源

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