# K043271: R2-Mri Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Inner Vision Biometrics Pty, Ltd.
- Decided: Jan 21, 2005 after 56 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: 3 generations back to K940172 (1994). 4 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994283: Mri- Magnetic Resonance Analytical Software System, Medis Medical Imaging Systems BV (2000) Summary page 2.
- K961969: Hitachi Stratis, MRH-1500 Magnetic Resonance Diagnostic Devices Version 6 Operating System Software, Hitachi Medical Systems America, Inc. (1996) Summary page 2.

## Most influential descendants
- K122035: Hepafat Scan (2013), 3 descendants of its own
- K201039: HepaFat-AI (2020), 2 descendants of its own
- K213960: LiverMultiScan v5 (LMSv5) (2022), 1 descendant of its own
- K253413: LiverMultiScan (v6.0) (2026), 0 descendants of its own
- K231459: HepaFatSmart (V2.0.0) (2023), 0 descendants of its own

## Indications for use
The R2-MRI Analysis System is an accessory diagnostic device to MRI scanners and is intended for diagnostic use to present images that reflect the magnetic resonance spectra for the determination of iron in the liver.

Source page: https://510kreport.com/device/K043271
Methodology: https://510kreport.com/methodology