# K063730: Dextroscope, Model MK10; Dextrobeam, Model MK3, MK4; Radiodexter, Model 1.0

- Pathway: 510(k) (Special)
- Applicant: Volume Interactions Pte, Ltd.
- Decided: Jan 31, 2007 after 44 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K071054: Radiodexter, Dextroscope, Dextrobeam, Models 1.0, MK10, MK3 & MK4 (2007), 0 descendants of its own

## 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. 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/K063730
Methodology: https://510kreport.com/methodology