K252947
- 510(k) number
- K252947
- Device name
- HistoSonics® Planning Tool
- Applicant
- HistoSonics, Inc. MN · US
- Product code
- QTZ — Radiological Image Processing Software For Ablation
- Decision date
- 2026-05-29
- Date received
- 2025-09-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252947.pdf
Official FDA record: K252947
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.