510(k) K252947 · QTZ Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
HistoSonics® Planning Tool
| Applicant | HistoSonics, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, May 29, 2026 |
| Received | Sep 15, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252947
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.