Devices · HistoSonics, Inc.

HistoSonics® Planning Tool

HistoSonics, Inc. is listed for HistoSonics® Planning Tool (K252947). The FDA list gives May 29, 2026 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QTZ as “Radiological Image Processing Software For Ablation Therapy Planning And Evaluation”: To provide radiological image processing tools for planning, monitoring, and evaluating ablation therapy. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K252947

Official FDA database record

Date of final decision

May 29, 2026

Company on the FDA list

HistoSonics, Inc.

Lead panel

Radiology

Primary product code

QTZ

openFDA device name for the code

Radiological Image Processing Software For Ablation Therapy Planning And Evaluation

Device class

2

Regulation number

892.2050

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary