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Lungpoint Virtual Bronchoscopic Navigation Vbn System

by Broncus Technologies, Inc. 510(k)

Active United States

510(k) K090095

Overview

The LungPoint Virtual Bronchoscopic Navigation VBN System is a computer-assisted image-based navigation software system. It provides real-time path navigation within the airways and localization guidance to targeted areas of interest in the lung to assist with lung biopsy and other procedures.

The system displays live and virtual views to guide the user along a planned path with a navigation accuracy of 3mm. It is designed to operate without the requirement for specialized, disposable instruments. This device has received FDA 510k clearance.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK090095 Date13 Mar 2009ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the primary function of the LungPoint VBN System?

    The LungPoint VBN System is a computer-assisted image-based navigation software platform designed to provide real-time path navigation and localization guidance within the lung airways to assist clinicians during lung biopsy and other procedures.

  • What is the navigation accuracy of the LungPoint system?

    The system provides a navigation accuracy of 3mm, allowing for precise guidance to targeted areas of interest within the lung during diagnostic or therapeutic procedures.

  • Does the LungPoint system require specialized disposable instruments?

    The LungPoint VBN System is designed to operate without the requirement for specialized, disposable instruments, which may offer flexibility in the selection of tools used during the procedure.

  • What is the regulatory status of the LungPoint VBN System?

    The LungPoint Virtual Bronchoscopic Navigation VBN System has received FDA 510k clearance, indicating it has been reviewed and found substantially equivalent to legally marketed predicate devices.