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FDA 510(k)

HistoSonics® Planning Tool

K-Number: K252947 · 2026-05-29

ApplicantHistoSonics, Inc.
Decision Date2026-05-29
Product CodeQTZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HistoSonics® Planning Tool is the device name listed in this FDA 510(k) record. The listed applicant is HistoSonics, Inc.. It received FDA 510(k) clearance on 2026-05-29 under 510(k) number K252947. The device is classified under product code QTZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HistoSonics® Planning Tool?

HistoSonics® Planning Tool is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is HistoSonics, Inc.. The 510(k) number is K252947.

When did HistoSonics® Planning Tool receive FDA 510(k) clearance?

HistoSonics® Planning Tool received FDA 510(k) clearance on 2026-05-29, under 510(k) number K252947.

Who is the listed applicant for HistoSonics® Planning Tool?

The FDA 510(k) record lists HistoSonics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HistoSonics® Planning Tool?

The FDA product code for HistoSonics® Planning Tool is QTZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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)RECRUITING

Other records listing HistoSonics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241902Edison SystemK233466Edison System

Related Devices (Code: QTZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253264myAblation Guide (VC10A)Siemens Healthcare GmbHK251931BioTraceIO Vision (V1.7)Techsomed Medical TechnologiesK240796myAblation Guide (VB80A)Siemens Healthcare GmbHK240773VisAble.IOTechsomedK222222Artemis, Artemis TPO, Artemis MXEigenK222938Ablation-fitR.A.W. S.R.L

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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