HistoSonics® Planning Tool is an AI-enabled medical device from HistoSonics, Inc., listed by FDA (510(k), K252947) with a decision date of 2026-05-29. Review panel: Radiology.
| FDA submission number | K252947 |
|---|---|
| Pathway | 510(k) |
| Company | HistoSonics, Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2026-05-29 |
| Decision | Substantially Equivalent |
| Product code | QTZ |
| Classification | Radiological Image Processing Software For Ablation Therapy Planning And Evaluation |
| Device class | 2 |
| Regulation number | 892.2050 |
| Review time (calendar days) | 256 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.