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Emprint Ablation Visualization Application

FDA 510(k)

Class II (US FDA 510(k))

510(k) K180192

by Covidien llc

Identifiers

510(k) Number
K180192 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Emprint Ablation Visualization Application is a software tool classified as a medical imaging software (Product Code: LLZ) under FDA guidelines. It is designed to assist in the visualization and planning of ablation procedures, enabling clinicians to map and monitor ablation zones in real time. By integrating with imaging systems, it enhances precision during microwave ablation treatments, supporting targeted tissue removal or destruction. The application aids in improving procedural accuracy and safety by providing detailed spatial data of the treatment area.

This application is supplied as a digital tool for use with compatible ablation systems and imaging platforms, requiring no physical sterilization or single-use considerations. It operates within standard clinical environments, including radiology suites, and is intended for use by trained professionals. The software does not require specific regulatory classifications beyond its FDA 510(k) clearance under the Radiology Advisory Committee (RA). No physical storage or sterility requirements apply, as it is a software-based solution deployed on compatible devices. Compliance is governed by the original FDA clearance (K180192) and applicable software validation standards.

Frequently asked questions

Is the Emprint Ablation Visualization Application a physical device that requires sterilization, or is it a software tool that runs on existing systems?

The Emprint Ablation Visualization Application is a software-only tool and does not require physical sterilization or single-use considerations. It integrates with compatible ablation systems and imaging platforms, operating digitally within standard clinical environments like radiology suites. Since it has no physical components, storage or sterility requirements are governed by standard IT and software deployment protocols rather than medical device sterilization standards.

How does this application help improve the accuracy of microwave ablation procedures, and what types of imaging systems does it work with?

The Emprint Ablation Visualization Application enhances precision during microwave ablation by providing real-time mapping and monitoring of ablation zones, allowing clinicians to visualize treatment areas spatially. While the exact compatible imaging systems aren’t detailed, the application is designed to integrate with standard radiology platforms used for ablation procedures, ensuring targeted tissue removal or destruction with improved accuracy and safety.

What regulatory pathway was followed for FDA clearance, and how does the Radiology Advisory Committee (RA) relate to its approval?

The Emprint Ablation Visualization Application received FDA 510(k) clearance (K180192) under the Radiology Advisory Committee (RA) as a substantially equivalent (SESE) device. The RA reviewed its submission to ensure compliance with radiology-related software standards, confirming its safety and effectiveness for visualization and planning of ablation procedures. The clearance is tied to its classification as medical imaging software (Product Code: LLZ).

Since this is a software application, are there any specific storage or environmental requirements for its use in a clinical setting?

No physical storage or environmental requirements apply beyond standard IT infrastructure for software deployment. The application runs on compatible devices within clinical environments like radiology suites, so it relies on the host system’s hardware and network connectivity. No special storage conditions (e.g., temperature, humidity) are mentioned, as it is entirely digital and governed by software validation standards rather than medical device storage protocols.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Emprint™ Ablation System - Apps on Google Play, Emprint™ Ablation System - Apps on Google Play, Emprint Visualization Application - Covidien | FDA Reference, Emprint Ablation Visualization Application - Covidien | FDA Reference

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Covidien llc
FDA Applicant
Covidien, LLC

Sources (1)

  • FDA 510(k) K180192 24 fields · synced Sep 20, 2026