# K241902: Edison System

- Pathway: 510(k) (Traditional)
- Applicant: HistoSonics, Inc.
- Decided: Oct 30, 2024 after 121 days
- Product code: QGM (Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation)
- Device class: 2
- Regulation: 21 CFR 878.4405
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN220087 (2023). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233466: Edison System, HistoSonics, Inc. (2024) Summary page 5.

## Indications for use
The Edison System is indicated for the non-invasive destruction of liver tumors, including unresectable liver tumors, using a non-thermal, mechanical process of focused ultrasound.

Source page: https://510kreport.com/device/K241902
Methodology: https://510kreport.com/methodology