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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceExablate Model 4000 Type 1.0 and 1.1 (“Exablate Neuro”; “Exablate Prime”)
Generic NameMR-guided focused ultrasound system
ApplicantInsightec
5 Nahum Heth St.
Tirat Carmel 39120
PMA NumberP150038
Supplement NumberS042
Date Received12/09/2025
Decision Date03/05/2026
Product Code POH 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to add a third-party remote connection software used for installation and configuration management and to add the Siemens CimaX MRI to the list of compatible platforms.
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