PMA P150038S005

Device: Exablate Model 4000 System
Applicant: Insightec
PMA number: P150038
Supplement: S005
Product code: POH
Decision date: 2018-09-20
Classification: Mr-guided Focused Ultrasound System
Generic name: MR-guided focused ultrasound system
Approval order statement: Approval for the Exablate 4000 Type 1.1 System, an expansion of the Exablate 4000 Type 1.0 System to add compatibility with Siemens 3T Skyra, Prisma and PrismaFIT MR systems, including hardware changes to the devices Helmet System, changes to the electronics of the devices Front End Cabinet, and changes to the device sub-systems required for connectivity with these Siemens MRI systems.

Current openFDA PMA Record#

Device: Exablate Model 4000 System
Applicant: Insightec
PMA number: P150038
Supplement: S005
Product code: POH
Generic name: MR-guided focused ultrasound system
Decision date: 2018-09-20
Decision code: APPR
Date received: 2018-02-20
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the Exablate 4000 Type 1.1 System, an expansion of the Exablate 4000 Type 1.0 System to add compatibility with Siemens 3T Skyra, Prisma and PrismaFIT MR systems, including hardware changes to the devices Helmet System, changes to the electronics of the devices Front End Cabinet, and changes to the device sub-systems required for connectivity with these Siemens MRI systems.