# K183453: VS3-IR

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic
- Decided: Mar 4, 2019 after 81 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K210265: VS3 Iridium Sytem (2021), 5 descendants of its own
- K222240: Explorer Air® II (2023), 1 descendant of its own
- K220477: Cellvizio 100 series system with confocal Miniprobes (2022), 1 descendant of its own
- K251852: cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) (2026), 0 descendants of its own
- K234090: EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) (2024), 0 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/K183453
Methodology: https://510kreport.com/methodology