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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 STREET
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
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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