# K231378: Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0

- Pathway: 510(k) (Traditional)
- Applicant: Insightec, Ltd.
- Decided: Oct 30, 2023 after 171 days
- Product code: PLP (High Intensity Ultrasound System For Prostate Tissue Ablation)
- Device class: 2
- Regulation: 21 CFR 876.4340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K160942 (2016). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212150: Exablate Prostate System, Insightec, Inc. (2021) Summary page 5.

## Indications for use
The Exablate Prostate System is indicated for endorectal MR-Guided Focused Ultrasound (MRgFUS) ablation of Prostatic Tissue.

Source page: https://510kreport.com/device/K231378
Methodology: https://510kreport.com/methodology