# K232227: Ablate-IQ

- Pathway: 510(k) (Traditional)
- Applicant: Neuwave Medical, Inc.
- Decided: Apr 4, 2024 after 252 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001284 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192427: Ablation Confirmation, Neuwave Medical, Inc. (2019) Summary page 4.

## Indications for use
ABLATE-IQ™ assists physicians in identifying ablation targets, assessing proper ablation probe placement and visualizing treatment zones when used with the NEUWAVE Microwave Ablation System (NEUWAVE System). The software is not intended for diagnosis, to predict ablation volume, or to predict ablation success.

Source page: https://510kreport.com/device/K232227
Methodology: https://510kreport.com/methodology