# K193281: Hepatic VCAR

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Mar 20, 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: 4 generations back to K871859 (1987). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133649: Hepatic Vcar, GE Medical Systems SCS (2014) Summary page 4.

## Most influential descendants
- K211180: Liver Suite (2022), 0 descendants of its own

## Indications for use
Hepatic VCAR is a CT image analysis software package that allows the analysis and visualization of Liver CT data derived from DICOM 3.0 compliant CT scans. Hepatic VCAR is designed for the purpose of assessing liver morphology, including liver lesion, provided the lesion has different CT appearance from surrounding liver tissue; and its change over time through automated tools for liver, liver lobe, liver segments and liver lesion segmentation and measurement. It is intended for use by clinicians to process, review, archive, print and distribute liver CT studies. This software will assist the user by providing initial 3D segmentation, vessel analysis, visualization, and quantitative analysis of liver anatomy. The user has the ability to adjust the contour and confirm the final segmentation.

Source page: https://510kreport.com/device/K193281
Methodology: https://510kreport.com/methodology