# K070464: ONDEMAND3D

- Pathway: 510(k) (Traditional)
- Applicant: Cybermed, Inc.
- Decided: Mar 16, 2007 after 28 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: 4 generations back to K954678 (1996). 10 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032760: Apax Pacs System, Tis, Inc. (2003) Summary page 1.
- K033849: Simplant System, Materialise NV (2004) Summary page 1.
- K022692: Voxelplus Pacs, Mevisys Co., Ltd. (2002) Summary page 1.

## Most influential descendants
- K113543: ONDEMAND3D (2011), 9 descendants of its own
- K131616: EZ3D-I, E3 (2013), 4 descendants of its own
- K150761: Ez3D-i/E3 (2015), 3 descendants of its own
- K161246: Ez3D-i / E3 (2016), 2 descendants of its own
- K102684: Xelis Dental (2010), 2 descendants of its own

## Indications for use
The OnDemand3DTM is intended for use as a software package which loads DICOM images from CT, MR, X-Ray, stores those and provides 3D visualization and 2D analysis, various MPR (Multi-Planar Reconstruction) functions for further rapid and precise diagnosis.

Source page: https://510kreport.com/device/K070464
Methodology: https://510kreport.com/methodology