Cleared Traditional

K090095 - LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGAT...

K090095 is an FDA 510(k) clearance for LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGAT..., manufactured by Broncus Technologies, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K090095 · Broncus Technologies, Inc. · Radiology device
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Mar 2009
Decision
57d
Days
Class 2
Risk

K090095 is an FDA 510(k) clearance for the LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Broncus Technologies, Inc. (Mountain View, US). The FDA issued a Cleared decision on March 13, 2009 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Broncus Technologies, Inc. devices

FDA 510(k) Submission Details - K090095

510(k) Number K090095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2009
Decision Date March 13, 2009
Days to Decision 57 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 107d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

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