# K210807: FlightPlan for Liver

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Oct 22, 2021 after 219 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: 4 generations back to K871859 (1987). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121200: Flightplan for Liver, GE Healthcare (2012) Summary page 4.

## Indications for use
FlightPlan for Liver is a post processing software package that helps the analysis of 3D X-ray angiography images of the liver. Its output is intended as an adjunct means to help visualize vasculature and identify arteries leading to the vicinity of hypervascular lesions in the liver. This adjunct information may be used by physicians to aid them in their evaluation of hepatic arterial anatomy during the planning phase of embolization procedures.

Source page: https://510kreport.com/device/K210807
Methodology: https://510kreport.com/methodology