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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 System (“Exablate Neuro”)
Generic NameMR-guided focused ultrasound system
ApplicantInSightec
5 NAHUM HETH STREET
TIRAT-HACARMET 39120
PMA NumberP150038
Supplement NumberS013
Date Received10/23/2020
Decision Date07/22/2021
Product Code POH 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for design changes to the Exablate Model 4000 Type 1.0 & 1.1 System (Exablate Neuro) to address the end-of-life of some of the system components; to support Exablate Neuro Type 1.1 imaging quality improvements to align with the imaging quality improvements approved for the Exablate Neuro Type 1.0 and to address minor software version 7.33 defects and usability aspects.
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