Exablate Neuro, Exablate Prime, Exablate Transcranial MRgFUS, Exablate Model 4000, Exablate Neuravive
FDA premarket approval P150038/S036 · decided 2024-10-08
Approval details
- PMA number
- P150038
- Supplement
- S036
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Exablate Neuro, Exablate Prime, Exablate Transcranial MRgFUS, Exablate Model 4000, Exablate Neuravive
- Generic name
- MR-guided focused ultrasound system
- Applicant
- Insightec
- Date received
- 2024-04-17
- Decision date
- 2024-10-08
- Days to decision
- 174 days
- Decision code
- APPR
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- 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
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