# K252947: HistoSonics® Planning Tool

- Pathway: 510(k) (Traditional)
- Applicant: HistoSonics, Inc.
- Decided: May 29, 2026 after 256 days
- Product code: QTZ (Radiological Image Processing Software For Ablation Therapy Planning And Evaluation)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K954678 (1996). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192038: Emprint Visualization Application, Covidien, LLC (2019) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K252947
Methodology: https://510kreport.com/methodology