# Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
> **Product code: 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NRZ)
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