# K071054: Radiodexter, Dextroscope, Dextrobeam, Models 1.0, MK10, MK3 & MK4

- Pathway: 510(k) (Traditional)
- Applicant: Volume Interactions Pte, Ltd.
- Decided: May 22, 2007 after 36 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: 1 generation back to K063730 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063730: Dextroscope, Model MK10; Dextrobeam, Model MK3, MK4; Radiodexter, Model 1.0, Volume Interactions Pte, Ltd. (2007) Summary page 1.

## 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 tomographic radiology images, excluding mammography images. It is intended to be used by qualified and trained medical professionals, after proper installation.

Source page: https://510kreport.com/device/K071054
Methodology: https://510kreport.com/methodology