# K210918: da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System

- Pathway: 510(k) (Special)
- Applicant: Intuitive Surgical, Inc.
- Decided: Apr 26, 2021 after 28 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- 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: 15 generations back to K930667 (1994). 81 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K124031: DA Vinci Fluorescence Imaging Vision System, Intuitive Surgical, Inc. (2013) Summary page 4.
- K141077: DA Vinci Firefly Imaging System, Intuitive Surgical, Inc. (2014) Summary page 4.

## Most influential descendants
- K213710: da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System (2022), 2 descendants of its own
- K212101: da Vinci SP Firefly Imaging System (2021), 2 descendants of its own
- K250786: SP Endoscope, 0° (430600) (2025), 1 descendant of its own
- K252350: da Vinci SP Firefly Imaging System (2025), 0 descendants of its own
- K233892: 3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF) (2024), 0 descendants of its own

## Indications for use
Da Vinci Fluorescence Imaging Vision System: The da Vinci Fluorescence Imaging Vision System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Fluorescence Imaging Vision System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the da Vinci Fluorescence Imaging Vision System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization. Da Vinci Firefly Imaging System: The da Vinci Firefly Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci Firefly Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct or common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the da Vinci Firefly Imaging System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

Source page: https://510kreport.com/device/K210918
Methodology: https://510kreport.com/methodology