DevicePMAs@therightstef:P110039_S000 JSONTXT

Approval for the exablate system, model 2000/2100 /2100 vi. this device is indicated for pain palliation of metastatic bone cancer in patients 18 years of age or older who are suffering from bone pain due to metastatic disease and who arc failures of standard radiation therapy, or not candidates for, or refused radiation therapy. the bone tumor to be treated must be visible on non-contrast mr and device accessible.