Vectorvision FLUORO3D
FDA 510(k)Class II (US FDA 510(k))
by Brainlab AG
Identifiers
- 510(k) Number
- K024192 FDA 510(k)
- FDA Product Code
- HAW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Vectorvision Fluoro3D is an intraoperative image-guided localization system designed for computer-assisted navigation of medical image data. It functions by linking a freehand probe, tracked by a passive marker sensor system, to virtual computer image space on preoperative or intraoperative 2D or 3D image data. The system enables minimally invasive surgery and provides tools for screw implant size planning and navigation on rigid bone structures.
This device is authorized under FDA 510(k) clearance. It is intended for use in clinical settings to assist surgeons with image-guided procedures. Users should refer to the system user manual for specific operational instructions and safety information.
Frequently asked questions
What is the primary function of the Vectorvision Fluoro3D?
The Vectorvision Fluoro3D is an intraoperative image-guided localization system. It functions by linking a freehand probe, tracked by a passive marker sensor system, to virtual computer image space, allowing surgeons to navigate preoperative or intraoperative 2D or 3D image data during minimally invasive surgery.
Can this system be used for implant planning?
Yes, the system provides specific tools for screw implant size planning and navigation on rigid bone structures, assisting surgeons in achieving precise placement during procedures.
What is the regulatory status of this device?
The Vectorvision Fluoro3D is authorized under FDA 510(k) clearance. It has been determined to be substantially equivalent to other devices for the purpose of computer-assisted navigation of medical image data.
Where can I find operational instructions for this system?
Users should refer to the official system user manual provided by Brainlab AG. The manual contains specific operational instructions and essential safety information required for the proper use of the device in clinical settings.
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: PDF 510 (k)Summary of Safety and Effectiveness for VectorVision fluoro 3D, BRAINLAB VECTORVISION SYSTEM USER'S MANUAL Pdf Download, VV FLUORO 3D (K070106) — FDA 510(k) | Innolitics, VECTORVISION FLUORO3D (K024192) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K024192 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Brainlab AG
Sources (1)
- FDA 510(k) K024192 24 fields · synced Sep 27, 2026