# K082355: Visionsense Stereoscopic Vision System

- Pathway: 510(k) (Traditional)
- Applicant: Visionsense, Ltd.
- Decided: Dec 15, 2008 after 122 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: 4 generations back to K923160 (1992). 12 ancestors in all.
37 later devices descend from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081102: Vsu - Visionsense Stereoscopic Vision System, Visionsense, Ltd. (2008) Summary page 2.
- K073279: VS-Visionsense Stereoscopic Vision System, Visionsense, Ltd. (2008) Summary page 2.
- K051827: Joimax Endoscope/Multiscope, Thessys Foraminoscope/Multiscope, Thessys Laminoscope/Multiscope, Joimax GmbH (2005) Summary page 2.
- K990635: Vista Stereoscope System, Vista Medical Technologies, Inc. (1999) Summary page 2.

## Most influential descendants
- K141002: VS3 Stereoscopic High Definition Vision System (2014), 36 descendants of its own
- K152204: VS3-IR system (2015), 34 descendants of its own
- K162882: KARL STORZ ICG Imaging System (2017), 32 descendants of its own
- K171238: KARL STORZ ICG Imaging System (2017), 31 descendants of its own
- K180146: KARL STORZ ICG Imaging System (2018), 30 descendants of its own

## Indications for use
The VSII System is intended for viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, as well as for viewing internal surgical sites during general surgical procedures and for use in visualization of ventricles and structures within the brain during neurological surgical procedures.

Source page: https://510kreport.com/device/K082355
Methodology: https://510kreport.com/methodology