Exablate Model 4000 Type 1.0 and 1.1 System (Exablate Neuro)
FDA premarket approval P150038/S013 · decided 2021-07-22
Approval details
- PMA number
- P150038
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Exablate Model 4000 Type 1.0 and 1.1 System (Exablate Neuro)
- Generic name
- MR-guided focused ultrasound system
- Applicant
- Insightec
- Date received
- 2020-10-23
- Decision date
- 2021-07-22
- Days to decision
- 272 days
- Decision code
- APPR
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- Approval for design changes to the Exablate Model 4000 Type 1.0 & 1.1 System (Exablate Neuro) to address the end-of-life of some of the system components; to support Exablate Neuro Type 1.1 imaging quality improvements to align with the imaging quality improvements approved for the Exablate Neuro Type 1.0 and to address minor software version 7.33 defects and usability aspects.
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