• Subject is ≥18 years of age.

• 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.

• Subject is diagnosed with a non-metastatic solid renal mass ≤3cm confirmed via CT or MRI ≤ 30 days prior to the index procedure date.

• Subject can tolerate general anesthesia.

• Subject has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade 0-2 at baseline screening.

• 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

• Subject has an eGFR ≥45mL/min, ≤14 days prior to the planned index procedure date.

• International Normalized Ratio (INR) score of \<1.5:

‣ If on anticoagulants, other than aspirin or non-steroidal anti-inflammatory drugs, assessment must be performed on the day of the procedure; OR

⁃ If only on aspirin or non-steroidal anti-inflammatory drugs, assessment must be performed ≤14 days prior to the planned index procedure date; OR

⁃ If not on anticoagulants, assessment must be performed ≤14 days prior to the planned index procedure date

• Biopsy is required to determine the type of tumor and must be performed ≥14 days prior to the planned index procedure date.

⁃ The tumor selected for histotripsy treatment must be ≤3cm in longest diameter.

⁃ Subject has an adequate acoustic window to visualize targeted tumor using the HistoSonics Investigational System.

⁃ Subject will undergo histotripsy treatment of only one (1) tumor during the index procedure, regardless of how many tumors the subject has.