# K093810: BF-Navi

- Pathway: 510(k) (Traditional)
- Applicant: Kgt, Inc.
- Decided: Jun 18, 2010 after 189 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K926514 (1993). 29 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 31 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083227: Vida Pulmonary Workstation 2 (PW2), Vida Diagnostics, Inc. (2008) Summary page 1.
- K080581: VB Image Viewer, Olympus Medical Systems Corporation (2008) Summary page 1.
- K080271: Inreach System, Superdimension, Ltd. (2008) Summary page 1.

## Most influential descendants
- K121449: Directpath (2012), 0 descendants of its own

## Indications for use
Bf-NAVI is a virtual bronchoscopic navigation (VBN) software program designed to assist a physician during a bronchoscopic examination..The main purpose of the software is to generate a tracheobronchial tree using chest CT scan data in order to help the physician find an optimal bronchial route to the target region. Bf-NAVI allows the physician to view a 3D representation of the bronchial tree that displays virtual images of the inside surface of the bronchi. Bf-NAVI is intended for use only as a guidance tool and does not make any medical diagnosis.

Source page: https://510kreport.com/device/K093810
Methodology: https://510kreport.com/methodology