# K090295: Bodyviz, Model 100

- Pathway: 510(k) (Traditional)
- Applicant: Visual Medical Solutions, LLC
- Decided: Mar 4, 2009 after 27 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: 8 generations back to K942120 (1994). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072653: 3VISEON/Surgery, 3Mensio Medical Imaging BV (2008) Summary page 1.
- K082041: Fiatlux Visualize, Fiatlux Imaging, Inc. (2008) Summary page 1.

## Indications for use
BodyViz is a software device that receives digital images and data from various sources (i.e. CT scanner, MRI scanners). Data must be in DICOM format. Images and data are parsed, stored, processed, and displayed within the system as 3D representations. Image tools are available such as translation, rotation, scaling, clipping, and coloring. A data tool is available to window the displayed representation to certain tissue types based on tissue density (e.g., muscle, bone, or skin). Analysis of images and diagnosis is not performed by the software but by physicians or trained professionals.

Source page: https://510kreport.com/device/K090295
Methodology: https://510kreport.com/methodology