FDA 510(k)

肺點虛擬支氣管內視鏡導航（VBN）軟體

K 號：K260009 · 2026-04-24

決定日期2026-04-24

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

其他以 Broncus Medical, Inc. 為申請人之記錄

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相關器械（代碼：LLZ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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