# K083227: Vida Pulmonary Workstation 2 (PW2)

- Pathway: 510(k) (Traditional)
- Applicant: Vida Diagnostics, Inc.
- Decided: Nov 18, 2008 after 15 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: 6 generations back to K954355 (1995). 10 ancestors in all.
49 later devices descend from it; 12 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071513: Inspace 4D Software Package with Extended Functionality, Siemens Medical Solutions (2007) Summary page 2.

## Most influential descendants
- K151919: Vitrea CT Lung Density Analysis Software (2015), 10 descendants of its own
- K120648: Synapse 3D Lung and Abdomen Analysis (2012), 10 descendants of its own
- K123540: Syngo CT Pulmo 3D (2013), 9 descendants of its own
- K130542: Synapse 3D Lung and Abdomen Analysis (2013), 9 descendants of its own
- K183271: AI-Rad Companion (Pulmonary) (2019), 6 descendants of its own

## Indications for use
The VIDA Pulmonary Workstation 2 (PW2) software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. The PW2 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 Pulmonary Workstation 2 (PW2) 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/K083227
Methodology: https://510kreport.com/methodology