Radiology · 510(k) · 2026
HistoSonics Planning Tool
HistoSonics, Inc.. Cleared by FDA on 29 May 2026 under submission K252947, product code QTZ (radiological image processing software for ablation therapy planning and evaluation). What FDA's record says, in FDA's words.
Device record · K252947
- Device. HistoSonics Planning ToolDEVICE
- Company. HistoSonics, Inc.COMPANY
- Decision. 29 May 2026, 510(k), substantially equivalent (traditional review); received 15 September 2025DECISION
- Panel. RadiologyPANEL
- Product code. QTZ, Radiological Image Processing Software For Ablation Therapy Planning And EvaluationCODE
- Regulation. 21 CFR 892.2050, Class IIREG
- Source. FDA database entry · decision document (12 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The HistoSonics Planning Tool is a stand-alone software product that allows physicians to visualize and compare CT and MRI imaging data. The display, annotation, and volume rendering of medical images aids in histotripsy procedures conducted using HistoSonics Histotripsy Systems. The software is not intended for diagnosis. The software is used to evaluate images in the region of interest for patients deemed suitable for histotripsy by the treating physician.
The product code's definition, from FDA's classification record. To provide radiological image processing tools for planning, monitoring, and evaluating ablation therapy.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedCT, MRI
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code QTZ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QTZ, in Radiology, or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.