Chrysalis Intelligence · Sponsors · HistoSonics, Inc.

HistoSonics, Inc.

Plymouth, MN, US · 4 510(k) clearances

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals

Total clearances

4

2023-10-06 → 2026-05-29

Last 12 months

1

Product codes

2

Most recent

2026-05-29

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
QGM	Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation	Class II	General, Plastic Surgery	3	2024-10-30
QTZ	Radiological Image Processing Software For Ablation Therapy Planning And Evaluation	Class II	Radiology	1	2026-05-29

Filings

All 510(k) clearances (4)

Date	K-number	Device	Code	Class	Specialty
2026-05-29	K252947	HistoSonics® Planning Tool	QTZ	Class II	Radiology
2024-10-30	K241902	Edison System	QGM	Class II	General, Plastic Surgery
2024-03-13	K233466	Edison System	QGM	Class II	General, Plastic Surgery
2023-10-06	DEN220087	Edison System	QGM	Class II	General, Plastic Surgery