# K192038: Emprint Visualization Application

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Dec 2, 2019 after 125 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: 10 generations back to K954678 (1996). 22 ancestors in all.
1 later device descends 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)
- K180192: Emprint Ablation Visualization Application, Covidien, LLC (2018) Summary page 4.

## Most influential descendants
- K252947: HistoSonics® Planning Tool (2026), 0 descendants of its own

## Indications for use
The Emprint™ Visualization Application is a stand-alone software product that allows physicians to visualize and compare CT and MRI 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/K192038
Methodology: https://510kreport.com/methodology