# K210265: VS3 Iridium Sytem

- Pathway: 510(k) (Traditional)
- Applicant: Visionsense, Ltd.
- Decided: Nov 22, 2021 after 294 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: 19 generations back to K930667 (1994). 88 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183453: VS3-IR, Medtronic (2019) Summary page 4.
- K191851: VS3-IR, Medtronic (2019) Summary page 4.

## Most influential descendants
- 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
- K223020: VS3-Iridium System (VS3-IR) (2022), 0 descendants of its own

## Indications for use
Upon intravenous administration and use of an ICG consistent with its approved labeling, the Iridium Module of the VS3-IR System is used to perform intraoperative fluorescence angiography. Upon interstitial administration and use of ICG consistent with its approved labeling, the Endoscope configuration of the VS3-IR 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-IR 785 nm System is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

Source page: https://510kreport.com/device/K210265
Methodology: https://510kreport.com/methodology