# K113543: ONDEMAND3D

- Pathway: 510(k) (Traditional)
- Applicant: Cybermed, Inc.
- Decided: Dec 16, 2011 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: 6 generations back to K954874 (1996). 38 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070464: ONDEMAND3D, Cybermed, Inc. (2007) Summary page 1.
- K033849: Simplant System, Materialise NV (2004) Summary page 1.
- K070803: Invivodental, Anatomage, Inc. (2007) Summary page 1.
- K061370: Cardiq Fusion, GE Healthcare (2006) Summary page 2.

## Most influential descendants
- 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
- K163539: Ez3D-i / E3 (2016), 1 descendant of its own
- K152746: Ez3D Plus (2016), 1 descendant of its own

## Indications for use
The OnDemand3D G2 is intended for use as a software package which loads DICOM images from CT, MR, X-Ray, stores those and provides 3D visualization and 20 analysis, various MPR (Multi-Planar Reconstruction) functions for further rapid and precise diagnosis. It also provides the following functions as shown below. 1) Functions for implant surgery planning and fabricating a surgical guide according to the plan 2) Functions to combine and show the image data from different modalities such as CT, MRI and PET in one window at the same time 3) Functions to create orthodontic analysis using 3D volume data 4) Functions to sort and save DICOM files, Project Files and 2D image files from different modality [Panorama, Cephalometric, intraoral] under a single patient name

Source page: https://510kreport.com/device/K113543
Methodology: https://510kreport.com/methodology