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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 2100/2100 VI System
Generic NameAblation system, high intensity focused ultrasound (HIFU), MR-guided
ApplicantInsightec
5 Nahum Heth St.
Tirat Carmel 39120
PMA NumberP110039
Supplement NumberS008
Date Received09/22/2017
Decision Date01/25/2018
Product Code NRZ 
Advisory Committee General & Plastic Surgery
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 1) Software maintenance update to the currently approved clinical software (SW) Versions 6.24 (Windows-XP)/6.241 (Windows-7) used in the Exablate Model 2100/ 2100V1 Type 1.1 / Type 1.11 System (referred to as Exablate Bone or the system). The new software revision will be Version 6.57 (Windows-XP)/6.58 (Windows-7) (6.57 is a set of enhancements to the SW; 6.58 is an update to Windows 7 OS compatibility); and 2) Addition of a water bag as an accessory for acoustic coupling. The water bag will be provided as an optional accessory to be used as an alternative to the previously-approved gel pad.
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