Exablate Model 4000 System
FDA PMAClass III (US FDA PMA)
by Insightec
Identity
- Trade Name
- EXABLATE FDA PMA
- Generic Name
- MR-guided focused ultrasound system FDA PMA
Identifiers
- PMA Number
- P150038 FDA PMA
- FDA Product Code
- POH FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Neurology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Exablate Model 4000 System is an MR-guided focused ultrasound system indicated for use in the unilateral thalamotomy treatment of idiopathic essential tremor patients with medication-refractory tremor. It targets the ventralis intermedius nucleus in the brain for thermal ablation under MRI guidance.
This system is supplied as a non-sterile, reusable device intended for use in a clinical setting by trained professionals. It requires MRI compatibility for operation and is authorized under FDA PMA (P150038) for the specified neurological indication.
Frequently asked questions
What is the Exablate Model 4000 System indicated for?
The Exablate Model 4000 System is indicated for use in the unilateral thalamotomy treatment of idiopathic essential tremor patients with medication-refractory tremor, targeting the ventralis intermedius nucleus in the brain for thermal ablation under MRI guidance.
Is the Exablate Model 4000 System sterile or single-use?
The Exablate Model 4000 System is supplied as a non-sterile, reusable device and is not intended for single-use applications.
What regulatory authorization does the Exablate Model 4000 System have?
The Exablate Model 4000 System is authorized under FDA Premarket Approval (PMA) with PMA number P150038, as stated in the device data.
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 | P150038 | Class III | Active |
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Manufacturer
- Manufacturer
- Insightec
Sources (1)
- FDA PMA P150038 24 fields · synced Sep 18, 2026