De Novo · Granted
GrantedEdison System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
HistoSonics, Inc. · QGM Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation
Granted on Oct 6, 2023 as a new device type through De Novo after a 308-day review. 2 later devices descend from it.
- Decided
- Oct 6, 2023
- Review
- 308 days
- Class
- Class II
- Product code
- QGM
- Recalls
- None
2 later devices descend from it, 1 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN220087 | Edison System | HistoSonics, Inc. | 2023 | — |
| +1 | K233466 | Edison System | HistoSonics, Inc. | 2024 | — |
| +2 | K241902 | Edison System | HistoSonics, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QGM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QGM device
- #1 K233466 Edison Systemscore 10.0 · 1 generation · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233466 | Edison System | 2024 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K233466 (HistoSonics, Inc., 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All QGM devicesQGM Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QGM
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QGM
Too few QGM 510(k)s in any year since 2007 to give a median.
Recalls per year · QGM
No recall names QGM since 2007.
Adverse event reports per year · QGM
43in 2025
MAUDE reports naming product code QGM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 43 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN220087 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN220087: Edison System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN220087
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026