Identity
- Trade Name
- EXABLATE FDA PMA
- Generic Name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided FDA PMA
Identifiers
- PMA Number
- P110039 FDA PMA
- FDA Product Code
- NRZ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- General, Plastic Surgery FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Exablate System is an MR-guided high intensity focused ultrasound (HIFU) ablation system designed for medical procedures. It is indicated for the pain palliation of metastatic bone cancer in patients 18 years of age or older who are suffering from bone pain due to metastatic disease.
This device is intended for patients who are failures of standard radiation therapy, or who are not candidates for or have refused radiation therapy. The bone tumor targeted for treatment must be visible on non-contrast MR and accessible by the device. The system is authorized under FDA PMA P110039.
Frequently asked questions
What is the primary indication for the Exablate System?
The Exablate System is indicated for the pain palliation of metastatic bone cancer in adult patients who have failed, are not candidates for, or have refused standard radiation therapy.
How does the Exablate System guide treatment?
The system is an MR-guided high intensity focused ultrasound (HIFU) device, meaning it utilizes magnetic resonance imaging to visualize the bone tumor and guide the ablation process.
Are there specific requirements for the tumor to be treated?
Yes, the bone tumor must be visible on non-contrast MR imaging and must be accessible by the device to ensure safe and effective treatment.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P110039 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Insightec
Sources (1)
- FDA PMA P110039 24 fields · synced Sep 18, 2026