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VIZDEXTER VERSION 2.0 - Dextrobeam MK3

by Volume Interactions Pte, Ltd. 510(k)

Active United States

510(k) K022938

Overview

This device is a System, Image Processing, Radiological device designed to process tomographic imaging data, including CT and MRI scans, and generate stereoscopic 3D visualizations. It facilitates surgical planning and visualization by converting raw imaging data into three-dimensional renderings for enhanced spatial orientation and precision.

The system is supplied as three modular components: Vizdexter Version 2.0 (software), Dextroscope Mk8, and Dextrobeam Mk3, and is intended for use in radiology settings. It is classified under product code LLZ and holds an FDA 510(k) clearance (K022938) with a decision date of October 25, 2002. No sterility, single-use, or MRI safety specifications are noted in the available data.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK022938 Date25 Oct 2002ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
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  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
Models / Variants
Dextrobeam MK3
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Volume Interactions Pte, Ltd.

Questions

  • What is the primary purpose of the VIZDEXTER VERSION 2.0 system in a clinical setting?

    The VIZDEXTER VERSION 2.0 system is designed to process tomographic imaging data from CT and MRI scans, converting them into stereoscopic 3D visualizations. This helps surgeons and radiologists improve spatial orientation and precision during surgical planning by providing detailed three-dimensional renderings of anatomical structures.

  • How is the VIZDEXTER system supplied, and what are its modular components?

    The system is supplied as three separate modular components: the Vizdexter Version 2.0 (software), the Dextroscope Mk8, and the Dextrobeam Mk3. These components work together to process imaging data and generate 3D visualizations for surgical planning.

  • Is the VIZDEXTER VERSION 2.0 system intended for single-use or reusable applications?

    The available data does not specify whether the system or its components are single-use or reusable. Since it is a software-based imaging system with hardware components (Dextroscope Mk8 and Dextrobeam Mk3), typical usage would depend on manufacturer guidelines, which are not detailed in the provided information.

  • What regulatory pathway was followed for FDA clearance of this device?

    The VIZDEXTER VERSION 2.0 system received FDA clearance through a Traditional 510(k) pathway, classified under product code LLZ (Radiology). The submission was reviewed by the Radiology (RA) Advisory Committee, and the device was determined to be Substantially Equivalent to a predicate. The clearance was granted on October 25, 2002, with the decision code SESE.