Exablate Model 4000 Type 1.0 & Type 1.1 System (Exablate Neuro)
FDA premarket approval P150038/S032 · decided 2024-01-08
Approval details
- PMA number
- P150038
- Supplement
- S032
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Exablate Model 4000 Type 1.0 & Type 1.1 System (Exablate Neuro)
- Generic name
- MR-guided focused ultrasound system
- Applicant
- Insightec
- Date received
- 2023-07-14
- Decision date
- 2024-01-08
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- 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
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