Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

HistoSonics, Inc.

FDA 510(k) & PMA Approved Devices — 3 products

Total Devices3
Categories2
Latest FDA decision2026-05-29
TypeNumberDevice NameCodeDateActions
510(k) K252947 HistoSonics® Planning ToolQTZ2026-05-29 View
510(k) K241902 Edison SystemQGM2024-10-30 View
510(k) K233466 Edison SystemQGM2024-03-13 View

Related Clinical Trials

NCT05820087The HistoSonics Edison™ System for Treatment of Primary Solid Renal Tumors Using Histotripsy (#HOPE4KIDNEY)ACTIVE_NOT_RECRUITINGNCT06282809The HistoSonics Edison™ System for Treatment of Pancreatic Adenocarcinoma Using HistotripsyRECRUITINGNCT06486454Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)RECRUITINGNCT07214675The Edison System for Treatment of Benign Prostatic Hyperplasia (BPH) Using HistotripsyRECRUITING
↑