# DEN220087: Edison System

- Pathway: De Novo (Direct)
- Applicant: HistoSonics, Inc.
- Decided: Oct 6, 2023 after 308 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K233466: Edison System (2024), 1 descendant of its own
- K241902: Edison System (2024), 0 descendants of its own

## 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/DEN220087
Methodology: https://510kreport.com/methodology