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Ideal IQ Software Option

FDA 510(k)

Class II (US FDA 510(k))

510(k) K103411

by Ge Medical Systems

Identifiers

510(k) Number
K103411 FDA 510(k)
FDA Product Code
LNH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1000 FDA 510(k)
Regulation Number
892.1000 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Ideal IQ Software Option is a software module designed for use with GE Magnetic Resonance Imaging (MRI) systems. It enhances image acquisition and reconstruction, enabling high-resolution visualization of internal anatomical structures in transverse, sagittal, coronal, and oblique planes.

This software option is intended for integration with compatible GE MRI systems and is supplied as a digital download or installation package. It is classified as a Class II medical device under FDA regulations (892.1000) and has received 510(k) clearance (K103411) for radiology applications. No sterility or single-use requirements are specified, and its use is limited to MRI-compatible environments.

Frequently asked questions

What types of MRI systems is the Ideal IQ Software Option designed to work with, and how is it delivered to customers?

The Ideal IQ Software Option is designed exclusively for integration with compatible GE Magnetic Resonance Imaging (MRI) systems. It is supplied as a digital download or installation package, meaning it is not a physical device but rather a software module that must be installed on eligible GE MRI systems.

Is the Ideal IQ Software Option intended for single-use or repeated use, and are there any sterility requirements?

The Ideal IQ Software Option is not a physical consumable or disposable device, so it is not intended for single-use. Since it is a software module installed on MRI systems, there are no sterility requirements specified. It is designed for repeated use within MRI-compatible environments.

What types of anatomical planes does the Ideal IQ Software Option enhance visualization for, and how does it improve imaging?

The Ideal IQ Software Option enhances image acquisition and reconstruction to enable high-resolution visualization of internal anatomical structures across multiple planes: transverse, sagittal, coronal, and oblique. This means it helps clinicians obtain clearer and more detailed images for diagnostic purposes.

How is the regulatory status of the Ideal IQ Software Option determined, and what does this mean for users?

The Ideal IQ Software Option is classified as a Class II medical device under FDA regulations (892.1000) and has received 510(k) clearance (K103411) for radiology applications. This means it has undergone FDA review to ensure its safety and effectiveness for its intended use, providing users with confidence in its regulatory compliance for MRI-based diagnostic imaging.

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: GE Ideal Iq Software Option - allmed.wiki, FDA Browser - Cleared 510 (K) - IDEAL IQ SOFTWARE OPTION (K103411), Ideal Iq Software Option - Beudamed, GE Healthcare Ideal | allmed.wiki

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ge Medical Systems

Sources (1)

  • FDA 510(k) K103411 24 fields · synced Oct 6, 2026