# K133385: Lungpoint Atv Planning and Navigation Software

- Pathway: 510(k) (Traditional)
- Applicant: Broncus Medical, Inc.
- Decided: Feb 26, 2014 after 113 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K926514 (1993). 76 ancestors in all.
No later device cites it as a predicate yet.
1 of 77 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112051: Lungpoint Planning and Virtual Bronchoscopic Navigation (VBN) Software, Broncus Technologies, Inc. (2011) Summary page 1.
- K093423: Lungpoint Procedure Planning, Broncus Technologies, Inc. (2009) Summary page 1.
- K101311: EP Navigator R3, Philips Medical Systems North America Co. (2010) Summary page 1.

## Indications for use
The LungPoint®&ATV Planning and Navigation Software is indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools and catheters in the pulmonary tract to a location in the tracheobronchial tree or lung tissue, and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not for pediatric use. When under fluoroscopy guidance, the software enables users to segment previously acquired 3D CT dlatasets and overlay and register these 3D segmented data sets with live fluoroseopy X-ray images of the same anatomy in order to support catheter/device navigatjon. The 3D segmented data set can be displayed with a color map annotation received from an external source. The LungPoint tools (needle, balloon dilator, and sheath) arc used with a bronchoscope, navigated by the LungPoint Software.

Source page: https://510kreport.com/device/K133385
Methodology: https://510kreport.com/methodology