# K103411: Ideal IQ Software Option

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Mar 22, 2011 after 120 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K962061 (1996). 12 ancestors in all.
5 later devices descend from it; 2 cite it directly.
4 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072998: Ideal Software Option for GE MR Scanners, Ge Medical Systems, LLC (2007) Summary page 1.

## Most influential descendants
- K122035: Hepafat Scan (2013), 3 descendants of its own
- K201039: HepaFat-AI (2020), 2 descendants of its own
- K231459: HepaFatSmart (V2.0.0) (2023), 0 descendants of its own
- K213776: LiverSmart (2021), 0 descendants of its own
- K133526: Mdixon-Quant (2014), 0 descendants of its own

## Indications for use
IDEAL [Q is a software option intended for use on GE MR systems. IDEAL IQ is capable of producing transverse, sagittal, coronal, and oblique images of internal structures of the body, including but not limited to, the musculoskeletal, breast, abdominal, and neurological systems. Specific anatomical regions that may be imaged include the abdomen, breast, spine, joints, and extremities. IDEAL IQ is an acquisition and reconstruction technique that simultaneously obtains independent images of hydrogen nuclei that resonate at different frequencies to provide separation of water and triglyceride fat. IDEAL IQ generates images of separated water and triglyceride fat, relative triglyceride fat fraction map, and tissue transverse magnetization relaxation. In the liver, the relative triglyceride fat fraction map is quantitative; it reflects the proton density (number of protons per unit volume) of triglyceride fat, divided by the sum of the proton density of triglyceride fat and the proton density of water, on a voxel-by-voxel basis. When interpreted by a trained physician, these images provide information that can aid in diagnosis.

Source page: https://510kreport.com/device/K103411
Methodology: https://510kreport.com/methodology