# K101077: DA Vinci Fluorescence Imaging Vision System, Model FF 100

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Feb 4, 2011 after 291 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K930667 (1994). 68 ancestors in all.
104 later devices descend from it; 3 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)
- K081137: Intuitive Surgical DA Vinci SI Surgical System: Model IS3000, Intuitive Surgical, Inc. (2009) Summary page 1.
- K091515: Spy Scope Intra-Operative Operating System, Novadaq Technologies, Inc. (2009)

## Most influential descendants
- K124031: DA Vinci Fluorescence Imaging Vision System (2013), 103 descendants of its own
- 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

## Recalls of this device
- Nov 21, 2014 · Class II · Z-0834-2015: The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging Procedure Kit box, the six-kit box, and the shipping box. If heat were to damage the material, the res
- Jun 8, 2013 · Class II · Z-1688-2013: Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly.

## Indications for use
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 using near infra-red imaging.

Source page: https://510kreport.com/device/K101077
Methodology: https://510kreport.com/methodology