# K022938: Vizdexter Version 2.0; Dextroscope MK8; Dextrobeam MK3

- Pathway: 510(k) (Traditional)
- Applicant: Volume Interactions Pte, Ltd.
- Decided: Oct 25, 2002 after 51 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K954678 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992654: Plug 'N View 3D, Version 1.0, Voxar Limited (1999) Summary page 1.
- K002519: Vitrea 2, Version 2.1, Vital Images, Inc. (2000) Summary page 2.

## Indications for use
Volume Interactions Pte Ltd’s Image Processing System is a medical device for the display and visualization of 3D medical image data derived from CT and MRI scans. It is intended to be used by qualified and trained medial professionals, after proper installation. Volume Interactions Pte Ltd’s Image Processing System is not intended to be used in direct contact with the patient nor is it intended to be connected to equipment that is used in direct contact with the patient.

Source page: https://510kreport.com/device/K022938
Methodology: https://510kreport.com/methodology