# K150018: VS3-IR-MMS System

- Pathway: 510(k) (Traditional)
- Applicant: Visionsense, Ltd.
- Decided: Jun 17, 2015 after 163 days
- Product code: OWN (Confocal Optical Imaging)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K944261 (1994). 6 ancestors in all.
35 later devices descend from it; 2 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063345: Spy Imaging System, Novadaq Technologies, Inc. (2007) Summary page 4.

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

## Recalls of this device
- Oct 17, 2022 · Class II · Z-0280-2023: Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface.
- Oct 17, 2022 · Class II · Z-0282-2023: Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface.
- Oct 17, 2022 · Class II · Z-0281-2023: XXX

## Indications for use
The Endoscope Module of the VS3-IR-MMS 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 Iridium Module of the VS3-IR-MMS 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.

Source page: https://510kreport.com/device/K150018
Methodology: https://510kreport.com/methodology