PMA P150038S013

Device: Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)
Applicant: Insightec
PMA number: P150038
Supplement: S013
Product code: POH
Decision date: 2021-07-22
Generic name: MR-guided focused ultrasound system
Approval order statement: Approval for design changes to the Exablate Model 4000 Type 1.0 & 1.1 System (Exablate Neuro) to address the end-of-life of some of the system components; to support Exablate Neuro Type 1.1 imaging quality improvements to align with the imaging quality improvements approved for the Exablate Neuro Type 1.0 and to address minor software version 7.33 defects and usability aspects.

Current openFDA PMA Record#

Device: Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)
Applicant: Insightec
PMA number: P150038
Supplement: S013
Product code: POH
Generic name: MR-guided focused ultrasound system
Decision date: 2021-07-22
Decision code: APPR
Date received: 2020-10-23
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for design changes to the Exablate Model 4000 Type 1.0 & 1.1 System (Exablate Neuro) to address the end-of-life of some of the system components; to support Exablate Neuro Type 1.1 imaging quality improvements to align with the imaging quality improvements approved for the Exablate Neuro Type 1.0 and to address minor software version 7.33 defects and usability aspects.