Identifiers
- 510(k) Number
- K222970 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 IQS is a software component that provides a Quality Score in real time to the Right Ventricle from the 4-chamber apical view of the heart. It is designed to calculate relevant medical parameters of structures and functions within the heart. This device is intended to be integrated by another computer programmer into their legally marketed ultrasound system.
The LVivo IQS is supplied as a software component and is not specified as single-use or reusable. It has FDA 510(k) clearance with the product code QIH and is substantially equivalent to the predicate device. The device is authorized for use in radiology applications and has model number K222970.
Frequently asked questions
What is the LVivo IQS software component used for?
The LVivo IQS is designed to calculate relevant medical parameters of structures and functions within the heart, specifically providing a real-time Quality Score for the Right Ventricle from the 4-chamber apical view. It is intended to be integrated by programmers into legally marketed ultrasound systems.
How is the LVivo IQS supplied and can it be reused?
The LVivo IQS is supplied as a software component without specification as single-use or reusable. As a software product, its reusability depends on how it's implemented within the ultrasound system rather than physical characteristics.
What regulatory approvals does the LVivo IQS have?
The LVivo IQS has FDA 510(k) clearance with product code QIH and is substantially equivalent to the predicate device. It is authorized for use in radiology applications with model number K222970.
How is the LVivo IQS integrated into ultrasound systems?
The LVivo IQS is designed to be integrated by another computer programmer into their legally marketed ultrasound system. It functions as a software component that enhances the ultrasound system's capabilities by providing real-time Quality Score analysis.
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: PDF DiA Imaging Analysis Ltd. ℅ George Hattub Medical Device Regulatory ..., K240769 FDA 510(k) - LVivo IQS | Dia Imaging Analysis, Ltd., K222970 FDA 510(k) - LVivo IQS | Dia Imaging Analysis, Ltd., LVivo IQS (K240769) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222970 | Class II | Active |
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Manufacturer
- Manufacturer
- Dia Imaging Analysis, Ltd.
Sources (1)
- FDA 510(k) K222970 24 fields · synced Sep 25, 2026