PMA P040003S002
- Device
- EXABLATE 2000
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S002
- Product code
- NRZ
- Decision date
- 2007-02-27
- 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 TO IMPLEMENT THE VERSION 4.2 SOFTWARE AND A NEW PATIENT TABLE (WITH OTHER RELATED HARDWARE) THAT ALLOW FOR OPERATION OF THE EXABLATE 2000 SYSTEM WITH THE GENERAL ELECTRIC 3T MAGNETIC RESONANCE IMAGING (MRI) SYSTEM. VERSION 4.2 SOFTWARE PROVIDES FOR AN INTERLEAVED MODE OF OPERATION, ELONGATED FOCAL SPOTS, AND A SCALE-ABLE COOLING DURING.
Current openFDA PMA Record#
- Device
- EXABLATE 2000
- Applicant
- Insightec, Ltd.
- PMA number
- P040003
- Supplement
- S002
- Product code
- NRZ
- Generic name
- Ablation system, high intensity focused ultrasound (HIFU), MR-guided
- Decision date
- 2007-02-27
- Decision code
- APPR
- Date received
- 2006-07-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO IMPLEMENT THE VERSION 4.2 SOFTWARE AND A NEW PATIENT TABLE (WITH OTHER RELATED HARDWARE) THAT ALLOW FOR OPERATION OF THE EXABLATE 2000 SYSTEM WITH THE GENERAL ELECTRIC 3T MAGNETIC RESONANCE IMAGING (MRI) SYSTEM. VERSION 4.2 SOFTWARE PROVIDES FOR AN INTERLEAVED MODE OF OPERATION, ELONGATED FOCAL SPOTS, AND A SCALE-ABLE COOLING DURING.