HistoSonics® Planning Tool— 510(k) K252947
Substantially EquivalentHistoSonics, Inc.
FDA 510(k) clearance K252947 for HistoSonics® Planning Tool, Substantially Equivalent on 2026-05-29. Applicant: HistoSonics, Inc.. Device class: 2.
Summary
The HistoSonics Planning Tool is from HistoSonics and is filed under QTZ, radiological image processing software for ablation therapy planning and evaluation.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. The submission was a Traditional 510(k).
HistoSonics filed from Plymouth, Minnesota. FDA received it on September 15, 2025 and found it substantially equivalent on May 29, 2026, 256 calendar days later.
Clearance details
- Applicant
- HistoSonics, Inc.
- Product code
- Product code QTZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plymouth, MN, US
Recent devices under product code QTZ
view allMore clearances from HistoSonics, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.