# K152204: VS3-IR system

- Pathway: 510(k) (Traditional)
- Applicant: Visionsense, Ltd.
- Decided: Oct 28, 2015 after 83 days
- Product code: OWN (Confocal Optical Imaging)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K944261 (1994). 41 ancestors in all.
34 later devices descend from it; 2 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091515: Spy Scope Intra-Operative Operating System, Novadaq Technologies, Inc. (2009) Summary page 4.
- K123467: VS3, Visionsense, Ltd. (2013) Summary page 5.
- K141002: VS3 Stereoscopic High Definition Vision System, Visionsense, Ltd. (2014) Summary page 5.
- K131434: VS3 Stereoscopic High Definition Vision System, Visionsense, Ltd. (2013) Summary page 5.
- K150018: VS3-IR-MMS System, Visionsense, Ltd. (2015) Summary page 5.

## Most influential descendants
- 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
- K211202: 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes (2021), 19 descendants of its own
- K214046: 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable (2022), 14 descendants of its own

## Indications for use
The 3D Endoscope Module of the VS3-IR System is intended for viewing internal surgical sites during general surgical procedures, for use in visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures. The MMS configuration of the Iridium Module of the VS3-IR System is intended for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures. The Endoscope configuration of the Iridium Module of the VS3-IR System is intended to provide real-time endoscopic visible and near infrared fluorescence imaging. Iridium Endoscope enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infrared imaging during minimally invasive surgery.

Source page: https://510kreport.com/device/K152204
Methodology: https://510kreport.com/methodology