# K200990: VIDAvision

- Pathway: 510(k) (Traditional)
- Applicant: Vida Diagnostics, Inc.
- Decided: Aug 7, 2020 after 114 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K954355 (1995). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083227: Vida Pulmonary Workstation 2 (PW2), Vida Diagnostics, Inc. (2008) Summary page 4.

## Most influential descendants
- K233875: Brainomix 360 e-Lung (2024), 1 descendant of its own
- K242411: Brainomix 360 e-Lung (2025), 0 descendants of its own

## Indications for use
The VIDA|vision software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. VIDA|vision can be used to support the physician in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, low density cluster analysis and reporting tools are combined with a dedicated workflow. The VIDA|vision software package is also intended to be a real-time interactive evaluation in space and time for CT volume data sets that provides the reconstruction of two dimensional images into a three-dimensional image format.

Source page: https://510kreport.com/device/K200990
Methodology: https://510kreport.com/methodology