# K061126: Accurex

- Pathway: 510(k) (Traditional)
- Applicant: Cybermed, Inc.
- Decided: May 9, 2006 after 15 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: 5 generations back to K954678 (1996). 9 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013878: Cybermed, Inc., V-Works, Cybermed, Inc. (2001) Summary page 1.
- K053155: Vimplant, Cybermed, Inc. (2005) Summary page 1.

## Most influential descendants
- K090607: Blue Sky Bio Plan, Version .38 (2009), 2 descendants of its own
- K190096: R2GATE (2019), 1 descendant of its own
- K223909: R2GATE Lite TM (2023), 0 descendants of its own

## Indications for use
Use as a software for the display and 3D visualization of dental image files from scanning devices such as CT, MRI for radiologists, dental clinicians and practitioners to acquire, process, render, review, store, print and distribute DICOM 3.0 complaint image studies, utilizing standard PC hardware.

Source page: https://510kreport.com/device/K061126
Methodology: https://510kreport.com/methodology