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FDA 510(k)

LungPoint Virtual Bronchoscopic Navigation (VBN) Software

K-Number: K260009 · 2026-04-24

ApplicantBroncus Medical, Inc.
Decision Date2026-04-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06962436RAB Versus Ultrathin Bronchoscopy With VBN in the Diagnosis of PPNsRECRUITINGNCT07682012LungVision AI-Augmented Fluoroscopic Navigation for Intraoperative Pulmonary Nodule LocalizationCOMPLETED

Other records listing Broncus Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232601BroncTru™ Transbronchial Access ToolK232038BioStar Single Use Transbronchial Aspiration NeedleK200702EasyPath RF Introducer SheathK183240Empower RF Catheter

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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