# K121449: Directpath

- Pathway: 510(k) (Traditional)
- Applicant: Cybernet Systems Co., Ltd.
- Decided: Jul 10, 2012 after 56 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: 10 generations back to K926514 (1993). 30 ancestors in all.
No later device cites it as a predicate yet.
1 of 31 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093810: BF-Navi, Kgt, Inc. (2010) Summary page 1.
- K083227: Vida Pulmonary Workstation 2 (PW2), Vida Diagnostics, Inc. (2008) Summary page 1.

## Indications for use
DirectPath is a virtual bronchoscopic navigation software program designed to assist the physician during 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. The DirectPath software allows the physician to view a three-dimensional representation of the bronchial tree that displays virtual images of the inside surface of the bronchi. DirectPath is intended for use only as a guidance tool and does not make any medical diagnosis.

Source page: https://510kreport.com/device/K121449
Methodology: https://510kreport.com/methodology