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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 System
Generic NameMR-guided focused ultrasound system
ApplicantInsightec
5 Nahum Heth St.
Tirat Carmel 39120
PMA NumberP150038
Supplement NumberS005
Date Received02/20/2018
Decision Date09/20/2018
Product Code POH 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order 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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