# K191579: Voyant System

- Pathway: 510(k) (Special)
- Applicant: Viseon, Inc.
- Decided: Jul 11, 2019 after 27 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K002931 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181885: Voyant System, Viseon, Inc. (2018) Summary page 4.

## Most influential descendants
- K213978: TELIGEN System (2022), 0 descendants of its own

## Indications for use
The Voyant System is indicated to provide minimally invasive access, visualization, illumination, and magnification of the surgical area of the spine.

Source page: https://510kreport.com/device/K191579
Methodology: https://510kreport.com/methodology