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Vectorvision2

FDA 510(k)

Class II (US FDA 510(k))

510(k) K983831

by Brainlab AG

Identifiers

510(k) Number
K983831 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)

The VectorVision2 is a surgical navigation device used for guidance during neurosurgical procedures. It provides real-time tracking and visualization of surgical instruments and anatomical structures to enhance precision and accuracy in the operating room.

The VectorVision2 is supplied as a reusable system and is not MRI compatible. It is authorized under FDA 510(k) clearance with product code HAW and was cleared on May 19, 1999. The device is manufactured by Brainlab AG and is intended for use in neurosurgical settings.

Frequently asked questions

What is the VectorVision2 used for in neurosurgical procedures?

The VectorVision2 is a surgical navigation device that provides real-time tracking and visualization of surgical instruments and anatomical structures to enhance precision and accuracy during neurosurgical procedures in the operating room.

Is the VectorVision2 MRI compatible and how is it supplied?

The VectorVision2 is supplied as a reusable system and is not MRI compatible. It is designed for repeated use in neurosurgical settings, though specific sterilization requirements would need to be followed between procedures.

What regulatory approvals does the VectorVision2 have?

The VectorVision2 is authorized under FDA 510(k) clearance with product code HAW and was cleared on May 19, 1999. It is manufactured by Brainlab AG and intended for use in neurosurgical settings.

Are there different models or sizes of the VectorVision2 available?

The device data does not specify different models or sizes of the VectorVision2. The information provided indicates a single system configuration designed for neurosurgical navigation purposes.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Brainlab AG

Sources (1)

  • FDA 510(k) K983831 24 fields · synced Sep 23, 2026