# K183210: Thoracic VCAR with GSI Pulmonary Perfusion

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Mar 29, 2019 after 130 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 K954355 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103480: Thoracic Vcar, Ge Medical Systems, LLC (2011) Summary page 4.

## Indications for use
Thoracic VCAR is a CT, non-invasive image analysis software package, which may be used in conjunction with CT lung images to aid in the assessment of thoracic disease. The software provides automatic segmentation of the lungs and automatic segmentation and tracking of the airway tree. Thoracic VCAR also provides quantification of Hounsfield units and display by color of thresholds within a segmented region. Thoracic VCAR also supports Gemstone Spectral Imaging (GSI) acquisitions for the evaluation of pulmonary perfusion. It provides additional information to aid in visualization of variations of perfusion within the lungs and to quantitatively assess lung volumes. It is intended to be used as an adjunct to current standard methods utilizing color coded displays of iodine attenuation differences in the lungs to aid in identifying segments of relative perfusion differences which may be useful in assessing thoracic disease. Thoracic diseases that may be associated with changes in perfusion include pulmonary embolism and COPD.

Source page: https://510kreport.com/device/K183210
Methodology: https://510kreport.com/methodology