PMA P150038S033

Device: Exablate Model 4000 Type 1.0 & Type 1.1 System (“Exablate Neuro”)
Applicant: Insightec
PMA number: P150038
Supplement: S033
Product code: POH
Decision date: 2024-01-21
Classification: Neurology
Generic name: MR-guided focused ultrasound system
Approval order statement: approval for a manufacturing site located at R.H. Electronics Ltd., 5 Hatzoref St. Har-Yona Industrial Area, Nof Hagalil, Nazereth Illit, 17000, Israel, for assembly activities of the Exablate Neuro treatment kits

Current openFDA PMA Record#

Device: Exablate Model 4000 Type 1.0 & Type 1.1 System (“Exablate Neuro”)
Applicant: Insightec
PMA number: P150038
Supplement: S033
Product code: POH
Generic name: MR-guided focused ultrasound system
Decision date: 2024-01-21
Decision code: APPR
Date received: 2023-11-22
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a manufacturing site located at R.H. Electronics Ltd., 5 Hatzoref St. Har-Yona Industrial Area, Nof Hagalil, Nazereth Illit, 17000, Israel, for assembly activities of the Exablate Neuro treatment kits