# P110039: Exablate

- Pathway: PMA
- Applicant: Insightec
- Decided: Oct 18, 2012 after 318 days
- Product code: NRZ (Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided)
- Device class: 3
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

Source page: https://510kreport.com/device/P110039
Methodology: https://510kreport.com/methodology