PMA P150038S023

Device: Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)
Applicant: Insightec
PMA number: P150038
Supplement: S023
Product code: POH
Decision date: 2022-11-02
Generic name: MR-guided focused ultrasound system
Approval order statement: Approval for the addition of another sterile disposable head ring screws (DHRS) option, manufactured by INSIGHTEC and marketed under a name PFK (Patient Fixation Kit), as an accessory to Exablate Neuro system.

Current openFDA PMA Record#

Device: Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)
Applicant: Insightec
PMA number: P150038
Supplement: S023
Product code: POH
Generic name: MR-guided focused ultrasound system
Decision date: 2022-11-02
Decision code: APPR
Date received: 2022-08-05
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the addition of another sterile disposable head ring screws (DHRS) option, manufactured by INSIGHTEC and marketed under a name PFK (Patient Fixation Kit), as an accessory to Exablate Neuro system.