LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE— 510(k) K112051

Name: FDA 510(k) clearance K112051
Creator: U.S. Food and Drug Administration
Published: 2011-10-12

Substantially Equivalent

Broncus Technologies, Inc.

FDA 510(k) clearance K112051 for LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE, Substantially Equivalent on 2011-10-12. Applicant: Broncus Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Broncus Technologies, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2011-07-18
Decision date: 2011-10-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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More clearances from Broncus Technologies, Inc.

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K093423 — LUNGPOINT PROCEDURE PLANNING2009-11-17
K091160 — LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM2009-05-05
K090853 — YIELD TISSUE SAMPLER2009-04-07
K090743 — YIELD MINI DOPPLER SYSTEM2009-04-03
K090095 — LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM2009-03-13

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.