The HistoSonics Investigational System for Treatment of Primary Solid Renal Tumors Using Histotripsy

The purpose of this trial is to evaluate the technical success and safety profile of the HistoSonics Investigational System for the treatment of primary solid renal tumors.

Inclusion Criteria: 1. Subject is ≥18 years of age. 2. Subject has signed the Ethics Committee (EC) approved trial Informed Consent Form (ICF) prior to any trial related tests/procedures and is willing to comply with trial procedures and required follow-up assessments. 3. Subject is diagnosed with a non-metastatic solid renal mass ≤3cm confirmed via CT or MRI ≤ 30 days prior to the index procedure date. 4. Subject can tolerate general anesthesia. 5. Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-2 at baseline screening. 6. Subject meets all the following functional criteria at ≤14 days prior to the planned index procedure date: * White Blood Cell (WBC) ≥3,000/mm3 * Absolute Neutrophil Count (ANC) ≥1,200/mm3 * Hemoglobin (Hgb) ≥9 g/dL * Platelet count ≥100,000/mm3 (≥100 10\*9/L) * White Blood Cell (WBC) ≤40 cells/µL via urinalysis * Albumin ≤300,000 mg/L via urinalysis 7. Subject has an eGFR ≥45mL/min, ≤14 days prior to the planned index procedure date. 8. International Normalized Ratio (INR) score of \