Oncology
HistoSonics Planning Tool
HistoSonics, Inc.
FDA
FDA-cleared AI medical device
Stand-alone software that lets physicians visualise and compare CT and MRI data, with display, annotation and volume rendering that aids histotripsy procedures performed with HistoSonics histotripsy systems; it is not intended for diagnosis and is used to evaluate images in the region of interest for patients the treating physician has deemed suitable for histotripsy.
FDA Submission Metadata
- Submission number
- K252947
- Decision date
- May 2026
- FDA panel
- Radiology
- Product code
- QTZ
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA