# K130552: CT Pulmonary Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Qi Imaging, LLC
- Decided: Jan 13, 2014 after 315 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: 12 generations back to K913770 (1991). 165 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 168 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 1.
- K113620: Myrian 1.11, Intrasense (2012) Summary page 1.

## Most influential descendants
- K181892: Ziostation2 (2018), 1 descendant of its own
- K200315: Ziostation2 (2020), 0 descendants of its own

## Indications for use
Ziostation is an image processing workstation software package designed to run on standard PC hardware. It provides for the viewing, quantification, manipulation, communication, printing, and management of medical images. It is intended for use by trained medical professionals to aid in their reading and review of such data. In addition, Ziostation has the following indication: The CT PULMONARY ANALYSIS software option is an independent image analysis software tool providing additional image process capabilities to the Ziostation system. The CT PULMONARY ANALYSIS option is intended to assist the physician in assessing possible airway obstruction.

Source page: https://510kreport.com/device/K130552
Methodology: https://510kreport.com/methodology