Cleared Special

K112051 - LUNGPOINT PLANNING AND VIRTUAL BRONCHOS...

K112051 is an FDA 510(k) clearance for LUNGPOINT PLANNING AND VIRTUAL BRONCHOS..., manufactured by Broncus Technologies, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Special 510(k) pathway after a 86-day FDA review.

K112051 · Broncus Technologies, Inc. · Radiology device
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Oct 2011
Decision
86d
Days
Class 2
Risk

K112051 is an FDA 510(k) clearance for the LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE. 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 October 12, 2011 after a review of 86 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Low regulatory complexity profile. 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 - K112051

510(k) Number K112051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2011
Decision Date October 12, 2011
Days to Decision 86 days
Submission Type Special
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
21d faster than avg
Panel avg: 107d · This submission: 86d
Pathway characteristics
Modification to existing cleared device. 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.

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