Cleared Special

K093423 - LUNGPOINT PROCEDURE PLANNING

K093423 is an FDA 510(k) clearance for LUNGPOINT PROCEDURE PLANNING, 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 14-day FDA review.

K093423 · Broncus Technologies, Inc. · Radiology device
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Nov 2009
Decision
14d
Days
Class 2
Risk

K093423 is an FDA 510(k) clearance for the LUNGPOINT PROCEDURE PLANNING. 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 November 17, 2009 after a review of 14 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 - K093423

510(k) Number K093423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2009
Decision Date November 17, 2009
Days to Decision 14 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
93d faster than avg
Panel avg: 107d · This submission: 14d
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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