ExAblate 4000 System (Exablate Neuro or the system)
FDA premarket approval P150038/S012 · decided 2020-04-14
Approval details
- PMA number
- P150038
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ExAblate 4000 System (Exablate Neuro or the system)
- Generic name
- MR-guided focused ultrasound system
- Applicant
- Insightec
- Date received
- 2019-08-08
- Decision date
- 2020-04-14
- Days to decision
- 250 days
- Decision code
- APPR
- Product code
- POH
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Tirat Carmel
- Statement
- Approval for changes to the Exablate Neuro to introduce software version 7.33, expand the use of the device with an additional Siemens 1.5 Tesla (T) Aera magnetic resonance imaging (MRI) scanner, and addition of a custom 1.5 T receive-only imaging coil for the Exablate 4000 Type 1.1 System and a custom 3.0 T receive-only imaging coil for the Exablate 4000 Type 1.0 System.
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