FDA.reportPublic FDA data

PMA P150038S036

Device
Exablate Neuro, Exablate Prime, Exablate Transcranial MRgFUS, Exablate Model 4000, Exablate Neuravive
Applicant
Insightec
PMA number
P150038
Supplement
S036
Product code
POH
Decision date
2024-10-08
Classification
Neurology
Generic name
MR-guided focused ultrasound system
Approval order statement
approval for the Exablate Model 4000 Type 1.1 System software version 9.0.1 to be compatible with Philips 1.5 Tesla (T) and 3.0 T magnetic resonance imaging (MRI) scanners, and the hardware and labeling were modified accordingly as a result of this proposed change. In addition, the P150038/S036 application proposed the following changes to the subject device:• Expanded tractography support, to allow the display of overlapping anatomical structures.• Added baseline thermometry averaging (compared to approved baseline calculation using the last “cold phase” image), for enhanced sound-to-noise ratio (SNR), within approved specifications.• Added a visual indication of auto-calibration process bar and tracking planning scan acquisition.• Enhanced cavitation monitoring mechanism requirements, to further improve the robustness of the monitoring to sporadic noises and reduce false cavitation alerts.• Added additional thermometry protocols for GE and Siemens MRI scanners as additional options for users.

Current openFDA PMA Record#

Device
Exablate Neuro, Exablate Prime, Exablate Transcranial MRgFUS, Exablate Model 4000, Exablate Neuravive
Applicant
Insightec
PMA number
P150038
Supplement
S036
Product code
POH
Generic name
MR-guided focused ultrasound system
Decision date
2024-10-08
Decision code
APPR
Date received
2024-04-17
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
approval for the Exablate Model 4000 Type 1.1 System software version 9.0.1 to be compatible with Philips 1.5 Tesla (T) and 3.0 T magnetic resonance imaging (MRI) scanners, and the hardware and labeling were modified accordingly as a result of this proposed change. In addition, the P150038/S036 application proposed the following changes to the subject device:• Expanded tractography support, to allow the display of overlapping anatomical structures.• Added baseline thermometry averaging (compared to approved baseline calculation using the last “cold phase” image), for enhanced sound-to-noise ratio (SNR), within approved specifications.• Added a visual indication of auto-calibration process bar and tracking planning scan acquisition.• Enhanced cavitation monitoring mechanism requirements, to further improve the robustness of the monitoring to sporadic noises and reduce false cavitation alerts.• Added additional thermometry protocols for GE and Siemens MRI scanners as additional options for users.