- Device
- Exablate Model 4000 Type 1.0 & Type 1.1 System (Exablate Neuro)
- Applicant
- Insightec
- PMA number
- P150038
- Supplement
- S032
- Product code
- POH
- Generic name
- MR-guided focused ultrasound system
- Decision date
- 2024-01-08
- Decision code
- APPR
- Date received
- 2023-07-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for design changes to the patient stop sonication button, image processing, and software for the Exablate Model 4000 Type 1.0 & Type 1.1 System