FDA product code POH: Mr-Guided Focused Ultrasound System
POH is the FDA product code for mr-guided focused ultrasound system. It is a Class III device, reviewed by the Neurology panel. Devices under POH reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Mr-Guided Focused Ultrasound System |
| Device class | Class III |
| Review panel | NE — Neurology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for POH devices
openFDA lists no recalls for product code POH.
Frequently asked questions
What is FDA product code POH?
POH is the FDA product code for mr-guided focused ultrasound system. It is a Class III device, reviewed by the Neurology panel.
What device class is POH?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code POH
- Run a recall and safety report across every POH manufacturer
- Watch product code POH 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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