# K080581: VB Image Viewer

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Oct 16, 2008 after 227 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: 4 generations back to K926514 (1993). 12 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042438: Superdimension/Bronchus, Superdimension, Ltd. (2004) Summary page 3.

## Most influential descendants
- K093810: BF-Navi (2010), 1 descendant of its own
- K121449: Directpath (2012), 0 descendants of its own

## Indications for use
This instrument has been designed to display virtual bronchoscopy images to be referenced by physicians as an aid to guiding endoscopic tools in the pulmonary tract. It does not make a diagnosis and is not an endoscopic tool.

Source page: https://510kreport.com/device/K080581
Methodology: https://510kreport.com/methodology