PMA P150038S042

Device: Exablate Model 4000 Type 1.0 and 1.1 (“Exablate Neuro”; “Exablate Prime”)
Applicant: Insightec
PMA number: P150038
Supplement: S042
Product code: POH
Decision date: 2026-03-05
Classification: Neurology
Generic name: MR-guided focused ultrasound system
Approval order statement: Approval to add a third-party remote connection software used for installation and configuration management and to add the Siemens CimaX MRI to the list of compatible platforms.

Current openFDA PMA Record#

Device: Exablate Model 4000 Type 1.0 and 1.1 (“Exablate Neuro”; “Exablate Prime”)
Applicant: Insightec
PMA number: P150038
Supplement: S042
Product code: POH
Generic name: MR-guided focused ultrasound system
Decision date: 2026-03-05
Decision code: APPR
Date received: 2025-12-09
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval to add a third-party remote connection software used for installation and configuration management and to add the Siemens CimaX MRI to the list of compatible platforms.