FDA product code · Neurology
Mr-Guided Focused Ultrasound System
1 FDA decision since 2016. No recall names this code.
An MR-Guided Focused Ultrasound System is intended to use high intensity focused ultrasound (HiFU) to heat and ablate soft tissue in the brain to treat neurological disorders. MR imaging and thermal mapping are used to plan and monitor the use of the device 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 POH 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 · POH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · POH
Too few POH 510(k)s in any year since 2007 to give a median.
Recalls per year · POH
No recall names POH since 2007.
Adverse event reports per year · POH
41in 2025
MAUDE reports naming product code POH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 3 | — | 0 | 5 |
| 2018 | 4 | — | 0 | 2 |
| 2019 | 2 | — | 0 | 33 |
| 2020 | 2 | — | 0 | 28 |
| 2021 | 2 | — | 0 | 35 |
| 2022 | 7 | — | 0 | 29 |
| 2023 | 7 | — | 0 | 29 |
| 2024 | 5 | — | 0 | 35 |
| 2025 | 5 | — | 0 | 41 |
| 2026 | 4 | — | 0 | — |
Planning a device in POH? 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