# K223020: VS3-Iridium System (VS3-IR)

- Pathway: 510(k) (Special)
- Applicant: Visionsense, Ltd.
- Decided: Oct 28, 2022 after 29 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: 20 generations back to K930667 (1994). 108 ancestors in all.
No later device cites it as a predicate yet.
0 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150018: VS3-IR-MMS System, Visionsense, Ltd. (2015) Summary page 4.
- K152204: VS3-IR system, Visionsense, Ltd. (2015) Summary page 4.
- K183453: VS3-IR, Medtronic (2019) Summary page 4.
- K191851: VS3-IR, Medtronic (2019) Summary page 4.
- K210265: VS3 Iridium Sytem, Visionsense, Ltd. (2021) Summary page 4.

## Indications for use
The VS3-Iridium System is intended to provide real-time visible and near infrared fluorescence imaging in both open and minimally invasive procedures. Upon intravenous administration and use of an ICG consistent with its approved labeling, the VS3-Iridium System is used to perform fluorescence imaging visualization of vessels, blood flow and tissue perfusion before during and after general minimally invasive surgical procedures and plastic, micro-, reconstructive surgeries. Upon interstitial administration and use of ICG consistent with its approved labeling, the Endoscope configuration of the VS3-Iridium System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. Upon administration and use of pafolacianine consistent with its approved labeling, the VS3-Iridium 785 nm System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

Source page: https://510kreport.com/device/K223020
Methodology: https://510kreport.com/methodology