PMA P110039
- Device
- Exablate 2100/2100V1 System
- Applicant
- Insightec
- PMA number
- P110039
- Supplement
- S010
- Product code
- NRZ
- Decision date
- 2018-08-16
- Classification
- Ablation System, High Intensity Focused Ultrasound (hifu), Mr-guided
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Approval order statement
- Approval for modification to the connector port between the MRI scanner and the ExAblate 2100/2100VI System.
Current openFDA PMA Record#
- Device
- Exablate 2100/2100V1 System
- Applicant
- Insightec
- PMA number
- P110039
- Supplement
- S010
- Product code
- NRZ
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Decision date
- 2018-08-16
- Decision code
- APPR
- Date received
- 2018-04-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modification to the connector port between the MRI scanner and the ExAblate 2100/2100VI System.