PMA P150038S039

Device: Exablate Model 4000 System Type 1.0 and 1.1 System (“Exablate Neuro”; “Exablate Prime”)
Applicant: Insightec
PMA number: P150038
Supplement: S039
Product code: POH
Decision date: 2025-06-03
Classification: Neurology
Generic name: MR-guided focused ultrasound system
Approval order statement: Approval for changes in the design of the Exablate Head Frame to include the option of anterior posts as a connection configuration and increase in inner diameter of the Patient Fixation Kit (PFK) Short Jacket adapter.

Current openFDA PMA Record#

Device: Exablate Model 4000 System Type 1.0 and 1.1 System (“Exablate Neuro”; “Exablate Prime”)
Applicant: Insightec
PMA number: P150038
Supplement: S039
Product code: POH
Generic name: MR-guided focused ultrasound system
Decision date: 2025-06-03
Decision code: APPR
Date received: 2025-03-06
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for changes in the design of the Exablate Head Frame to include the option of anterior posts as a connection configuration and increase in inner diameter of the Patient Fixation Kit (PFK) Short Jacket adapter.