FDA product code NRZ: Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
NRZ is the FDA product code for ablation system, high intensity focused ultrasound (hifu), mr-guided. It is a Class III device, reviewed by the Obstetrics and Gynecology panel. Devices under NRZ reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code.
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.
Classification
| Field | Value |
|---|---|
| Device name | Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided |
| Device class | Class III |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for NRZ devices
openFDA lists no recalls for product code NRZ.
Frequently asked questions
What is FDA product code NRZ?
NRZ is the FDA product code for ablation system, high intensity focused ultrasound (hifu), mr-guided. It is a Class III device, reviewed by the Obstetrics and Gynecology panel.
What device class is NRZ?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code NRZ
- Run a recall and safety report across every NRZ manufacturer
- Watch product code NRZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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