# K191851: VS3-IR

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic
- Decided: Nov 25, 2019 after 138 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: 18 generations back to K930667 (1994). 86 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182606: PINPOINT Endoscopic Fluorescence Imaging System, Novadaq Technologies Ulc. (Now A Part of Stryker) (2018) Summary page 4.

## 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
Upon intravenous administration and use of an ICG consistent with its approved label, 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 label, 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.

Source page: https://510kreport.com/device/K191851
Methodology: https://510kreport.com/methodology