Exablate Model 4000 System
FDA premarket approval P150038/S005 · decided 2018-09-20
Approval details
- PMA number
- P150038
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Exablate Model 4000 System
- Generic name
- MR-guided focused ultrasound system
- Applicant
- Insightec
- Date received
- 2018-02-20
- Decision date
- 2018-09-20
- Days to decision
- 212 days
- Decision code
- APPR
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- Approval for the Exablate 4000 Type 1.1 System, an expansion of the Exablate 4000 Type 1.0 System to add compatibility with Siemens 3T Skyra, Prisma and PrismaFIT MR systems, including hardware changes to the devices Helmet System, changes to the electronics of the devices Front End Cabinet, and changes to the device sub-systems required for connectivity with these Siemens MRI systems.
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