Mr-Guided Focused Ultrasound System
Basic Information
- Device Name
- Mr-Guided Focused Ultrasound System
- Trade Name
- Exablate Neuro, Exablate Prime, Exablate Transcranial MRgFUS, Exablate Model 4000, Exablate Neuravive
- PMA Number
- P150038
- Supplement Number
- S036
- Device Class
- FDA Class 3
- Product Code
- POH
- Generic Name
- MR-guided focused ultrasound system
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 8, 2024
- Date Received
- April 17, 2024
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
approval for the Exablate Model 4000 Type 1.1 System software version 9.0.1 to be compatible with Philips 1.5 Tesla (T) and 3.0 T magnetic resonance imaging (MRI) scanners, and the hardware and labeling were modified accordingly as a result of this proposed change. In addition, the P150038/S036 application proposed the following changes to the subject device: Expanded tractography support, to allow the display of overlapping anatomical structures. Added baseline thermometry averaging (compared to approved baseline calculation using the last cold phase image), for enhanced sound-to-noise ratio (SNR), within approved specifications. Added a visual indication of auto-calibration process bar and tracking planning scan acquisition. Enhanced cavitation monitoring mechanism requirements, to further improve the robustness of the monitoring to sporadic noises and reduce false cavitation alerts. Added additional thermometry protocols for GE and Siemens MRI scanners as additional options for users.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| POH | Mr-Guided Focused Ultrasound System | FDA class 3 | Unknown |