DeviceClearance

LungPoint Virtual Bronchoscopic Navigation (VBN) Software— 510(k) K260009

Substantially Equivalent

Broncus Medical, Inc.

FDA 510(k) clearance K260009 for LungPoint Virtual Bronchoscopic Navigation (VBN) Software, Substantially Equivalent on 2026-04-24. Applicant: Broncus Medical, Inc.. Device class: 2.

Summary

Broncus Medical's LungPoint Virtual Bronchoscopic Navigation (VBN) Software is filed under product code LLZ (System, Image Processing, Radiological).

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Broncus Medical filed from San Jose, California. The decision came 112 calendar days after FDA received it (January 2 to April 24, 2026).

Clearance details

Applicant
Broncus Medical, Inc.
Product code
Product code LLZ
Device class
Class 2
Regulation
21 CFR 892.2050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Jose, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LLZ

product code LLZ
Death
13
Total
13

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.