Da Vinci Fluorescence Imaging Vision System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K124031 FDA 510(k)
- FDA Product Code
- OWN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Da Vinci Fluorescence Imaging Vision System is a confocal optical imaging device designed to provide real-time endoscopic visible and near-infrared fluorescence imaging. It assists surgeons in visualizing blood flow, vessels, and major bile ducts by utilizing an injectable dye known as IndoCyanine Green.
This system is intended for use with the Da Vinci Xi or Da Vinci X surgical systems and requires the use of components supplied by Intuitive Surgical. It has received FDA 510(k) clearance for use in gastroenterology and urology procedures. Users must refer to the official user manual for specific operational requirements and compatibility guidelines.
Frequently asked questions
What is the primary function of the Da Vinci Fluorescence Imaging Vision System?
This system is a confocal optical imaging device designed to provide real-time endoscopic visible and near-infrared fluorescence imaging. It assists surgeons in the visualization of blood flow, vessels, and major bile ducts during surgical procedures.
Which surgical platforms are compatible with this imaging system?
The system is specifically intended for use with the Da Vinci Xi or Da Vinci X surgical systems. It requires the use of components supplied by Intuitive Surgical to ensure proper integration and performance.
What clinical specialties is this device cleared for?
The device has received FDA 510(k) clearance for use in gastroenterology and urology procedures. These specialties are identified as the intended clinical environments for the system's imaging capabilities.
Does the system require any external agents for imaging?
Yes, the system utilizes an injectable dye known as IndoCyanine Green to facilitate the visualization of blood flow, vessels, and bile ducts during the imaging process.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Da Vinci Surgical Instruments | Vision | Intuitive, 552467-06_A Firefly User Manual P9.book - Intuitive, PDF Fluorescence imaging for da Vinci X and da Vinci Xi surgical systems
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K124031 | Class II | Active |
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Manufacturer
- Manufacturer
- Intuitive Surgical, Inc.
Sources (1)
- FDA 510(k) K124031 24 fields · synced Sep 21, 2026