# K124031: DA Vinci Fluorescence Imaging Vision System

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Sep 13, 2013 after 259 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: 12 generations back to K930667 (1994). 69 ancestors in all.
103 later devices descend from it; 6 cite it directly.
0 of 173 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101077: DA Vinci Fluorescence Imaging Vision System, Model FF 100, Intuitive Surgical, Inc. (2011) Summary page 1.

## Most influential descendants
- K141077: DA Vinci Firefly Imaging System (2014), 87 descendants of its own
- K142310: Stryker Infrared Fluorescence (IRF) Imaging System (2014), 76 descendants of its own
- K150956: PINPOINT Endoscopic Fluorescence Imaging System (2016), 70 descendants of its own
- K161792: PINPOINT Endoscopic Fluorescence Imaging System (2016), 68 descendants of its own
- K182606: PINPOINT Endoscopic Fluorescence Imaging System (2018), 44 descendants of its own

## Indications for use
The do Vinci Fluorescence Imaging Vision System Is intended to provide real-time endoscopic visible and near-infrared fluorescence Imaging. The da VlnciO Fluorescence Imaging Vision System enables surgeons to perform minimally invasive surgery using standard endloscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extrahepatic bile ducts (cystic dudt, common bile duct and common hepatic dud), using near infrared imaging. Fluorescence imaging of biliary dudts with the da VinciO Fluorescence Imaging Vision System Is intended for use with standard of care white light and, when indicated, lntraoperatlve cholanglography. The device is not intended for standalone use for biliary dudt visualization.

Source page: https://510kreport.com/device/K124031
Methodology: https://510kreport.com/methodology