PMA P150038S028

Device: Exablate Model 400 Type 1.0 & Type 1.1, Exablate Transcranial MRgFUS, Exablate Neuro, Exablate TcMRgFUS, Exablate Neurav
Applicant: Insightec
PMA number: P150038
Supplement: S028
Product code: POH
Decision date: 2023-07-27
Classification: Neurology
Generic name: MR-guided focused ultrasound system
Approval order statement: Change to allow fully automated assembly of the coil isolation board PCB layout.

Current openFDA PMA Record#

Device: Exablate Model 400 Type 1.0 & Type 1.1, Exablate Transcranial MRgFUS, Exablate Neuro, Exablate TcMRgFUS, Exablate Neurav
Applicant: Insightec
PMA number: P150038
Supplement: S028
Product code: POH
Generic name: MR-guided focused ultrasound system
Decision date: 2023-07-27
Decision code: OK30
Date received: 2023-06-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to allow fully automated assembly of the coil isolation board PCB layout.