PMA P150038S012

Device: ExAblate 4000 System (Exablate Neuro or the system)
Applicant: Insightec
PMA number: P150038
Supplement: S012
Product code: POH
Decision date: 2020-04-14
Generic name: MR-guided focused ultrasound system
Approval order statement: Approval for changes to the Exablate Neuro to introduce software version 7.33, expand the use of the device with an additional Siemens 1.5 Tesla (T) Aera magnetic resonance imaging (MRI) scanner, and addition of a custom 1.5 T receive-only imaging coil for the Exablate 4000 Type 1.1 System and a custom 3.0 T receive-only imaging coil for the Exablate 4000 Type 1.0 System.

Current openFDA PMA Record#

Device: ExAblate 4000 System (Exablate Neuro or the system)
Applicant: Insightec
PMA number: P150038
Supplement: S012
Product code: POH
Generic name: MR-guided focused ultrasound system
Decision date: 2020-04-14
Decision code: APPR
Date received: 2019-08-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for changes to the Exablate Neuro to introduce software version 7.33, expand the use of the device with an additional Siemens 1.5 Tesla (T) Aera magnetic resonance imaging (MRI) scanner, and addition of a custom 1.5 T receive-only imaging coil for the Exablate 4000 Type 1.1 System and a custom 3.0 T receive-only imaging coil for the Exablate 4000 Type 1.0 System.