Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
NRZ · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
NRZ
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
OB
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
An MR-guided focused ultrasound system is intended to use HIFU to ablate soft tissue. MR imaging and thermal mapping are used to plan and monitor the use of ultrasound ablation before and during the procedure.