FDA 510(k)

LungPoint虚拟支气管镜导航（VBN）软件

K号: K260009 · 2026-04-24

决定日期2026-04-24

产品代码LLZ

咨询委员会RA

决定实质等同

器械摘要

LungPoint Virtual Bronchoscopic Navigation (VBN) Software is the device name listed in this FDA 510(k) record. The listed applicant is Broncus Medical, Inc.. It received FDA 510(k) clearance on 2026-04-24 under 510(k) number K260009. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LungPoint Virtual Bronchoscopic Navigation (VBN) Software?

LungPoint Virtual Bronchoscopic Navigation (VBN) Software is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Broncus Medical, Inc.. The 510(k) number is K260009.

When did LungPoint Virtual Bronchoscopic Navigation (VBN) Software receive FDA 510(k) clearance?

LungPoint Virtual Bronchoscopic Navigation (VBN) Software received FDA 510(k) clearance on 2026-04-24, under 510(k) number K260009.

Who is the listed applicant for LungPoint Virtual Bronchoscopic Navigation (VBN) Software?

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

What is the FDA product code for LungPoint Virtual Bronchoscopic Navigation (VBN) Software?

The FDA product code for LungPoint Virtual Bronchoscopic Navigation (VBN) Software is LLZ.

列明Broncus Medical, 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。

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官方来源

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