# K180192: Emprint Ablation Visualization Application

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Mar 21, 2018 after 56 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K954678 (1996). 21 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142048: Emprint Procedure Planning Application, Covidien, LLC (2014) Summary page 4.

## Most influential descendants
- K192038: Emprint Visualization Application (2019), 1 descendant of its own
- K252947: HistoSonics® Planning Tool (2026), 0 descendants of its own

## Indications for use
The Emprint™ Ablation Visualization Application is a stand-alone software product that allows physicians to visualize and compare CT imaging data. The display, annotation, and volume rendering of medical images aids in ablation procedures conducted using Emprint™ ablation systems. The software is not intended for diagnosis.

Source page: https://510kreport.com/device/K180192
Methodology: https://510kreport.com/methodology