# K161285: Ablation Confirmation

- Pathway: 510(k) (Special)
- Applicant: Neuwave Medical, Inc.
- Decided: Jun 29, 2016 after 51 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: 4 generations back to K001284 (2000). 6 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150313: Ablation Confirmation, Neuwave Medical, Inc. (2015) Summary page 4.

## Most influential descendants
- K171022: Ablation Confirmation (2017), 2 descendants of its own
- K192427: Ablation Confirmation (2019), 1 descendant of its own
- K232227: Ablate-IQ (2024), 0 descendants of its own

## Indications for use
Ablation Confirmation™ (AC), is a Computed Tomography (CT) image processing software package available as an optional feature for use with the Certus® 140 2.45 GHz Ablation System. AC is controlled by the user via an independent user interface on a second monitor separate from the Certus 140 user interface. AC imports images from CT scanners and facility PACS systems for display and processing during ablation procedures. AC assists physicians in identifying ablation targets, assessing proper ablation probe placement and confirming ablation zones. The software is not intended for diagnosis.

Source page: https://510kreport.com/device/K161285
Methodology: https://510kreport.com/methodology