# K103480: Thoracic Vcar

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Mar 7, 2011 after 101 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: 7 generations back to K954355 (1995). 11 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 16 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.
- K071513: Inspace 4D Software Package with Extended Functionality, Siemens Medical Solutions (2007) Summary page 1.

## Most influential descendants
- K223071: Xenoview VDP (2022), 0 descendants of its own
- K203783: ClariPulmo (2022), 0 descendants of its own
- K183210: Thoracic VCAR with GSI Pulmonary Perfusion (2019), 0 descendants of its own
- K143294: Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways (2015), 0 descendants of its own

## 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 diagnosis and management. The software will provide automatic segmentation of the lungs and automatic segmentation and tracking of the airway tree. The software will provide quantification of Hounsfield units and display by color the thresholds within a segmented region.

Source page: https://510kreport.com/device/K103480
Methodology: https://510kreport.com/methodology