# K211180: Liver Suite

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: May 2, 2022 after 377 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: 5 generations back to K871859 (1987). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193281: Hepatic VCAR, GE Medical Systems SCS (2020) Summary page 4.

## Indications for use
Liver Suite is an aiding tool for the clinician to review multi-phase liver CT images following LI-RADS® guidelines. Liver Suite is designed to help analyzing liver lesions in patients with known or suspected hepatocellular carcinoma (HCC). It provides optimized series display and a guided workflow to assess relevant clinical features for user-defined observations, to enable computation of a LI-RADS score. It is intended for use by healthcare professionals. The clinician remains ultimately responsible for the final assessment and diagnosis based on state-of-the-art practices, clinical judgment and interpretation of liver images or quantitative data.

Source page: https://510kreport.com/device/K211180
Methodology: https://510kreport.com/methodology