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Lvivo Seamless

FDA 510(k)

Class II (US FDA 510(k))

510(k) K212466

by Dia Imaging Analysis, Ltd.

Identifiers

510(k) Number
K212466 FDA 510(k)
FDA Product Code
QIH 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 Lvivo Seamless is an AI-enabled medical device designed to automatically analyze cardiac ultrasound images as part of a standard echocardiography exam workflow. It is a software solution that runs on a hospital's existing IT infrastructure or echo lab servers. The device is used to analyze images, operating behind the scenes. It is classified under the product code QIH. The Lvivo Seamless is an AI-based software solution.

The Lvivo Seamless is supplied as a software solution and is intended for use in a clinical setting. It has received FDA 510(k) clearance, with the decision description stating that it is substantially equivalent. The device is listed in the FDA's Artificial Intelligence-Enabled Medical Devices list, with the review advisory committee being Radiology. The Lvivo Seamless has the k number K212466 and is manufactured by Dia Imaging Analysis, Ltd.

Frequently asked questions

What is the Lvivo Seamless used for?

The Lvivo Seamless is used to automatically analyze cardiac ultrasound images as part of a standard echocardiography exam workflow, providing AI-enabled analysis in a clinical setting.

How is the Lvivo Seamless supplied?

The Lvivo Seamless is supplied as a software solution, designed to run on a hospital's existing IT infrastructure or echo lab servers.

Is the Lvivo Seamless cleared for use in the US?

Yes, the Lvivo Seamless has received FDA 510(k) clearance, with the decision description stating that it is substantially equivalent, and is listed in the FDA's Artificial Intelligence-Enabled Medical Devices list.

What type of infrastructure does the Lvivo Seamless require?

The Lvivo Seamless can run on a hospital's existing IT infrastructure or echo lab servers, making it a flexible solution for clinical settings.

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: K243331 FDA 510(k) - LVivo Seamless | Dia Imaging Analysis, Ltd., DiA Imaging Analysis Ltd.: LVivo Seamless (FDA-cleared AI medical ..., LVivo Seamless Review: Pricing, FDA Status & Alternatives | Physician ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Dia Imaging Analysis, Ltd.

Sources (1)

  • FDA 510(k) K212466 24 fields · synced Sep 24, 2026