FDA product code · Obstetrics and gynecology
Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided
2 FDA decisions since 2004. No recall names this code.
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.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NRZ at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · NRZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NRZ
Too few NRZ 510(k)s in any year since 2007 to give a median.
Recalls per year · NRZ
No recall names NRZ since 2007.
Adverse event reports per year · NRZ
2in 2025
MAUDE reports naming product code NRZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 2 |
| 2012 | 3 | — | 0 | 0 |
| 2013 | 5 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 5 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 3 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
Planning a device in NRZ? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report