# K023130: Eloquence, Integrated Functional Imaging System

- Pathway: 510(k) (Special)
- Applicant: Mri Devices Corp.
- Decided: Oct 11, 2002 after 21 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003899 (2001). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003899: Ifis-SA Integrated Fuctional Imaging System, Mri Devices Corp. (2001)

## Most influential descendants
- K052467: Brain Viewrx Viewer, Version 1.0 (2005), 5 descendants of its own
- K063031: Prism View, Model (2006), 2 descendants of its own
- K061255: Brainacquirerx / Brainprocessrx Data Suite Version 1.0 (2006), 2 descendants of its own
- K082964: Prism Acquire (Version 1.5), Prism Process (Version 1.5), Prism View (Version 2.5) (2009), 1 descendant of its own
- K060453: Aze Virtualplace (2006), 1 descendant of its own

## Recalls of this device
- Feb 6, 2020 · Class II · Z-1440-2020: Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor.

## Indications for use
To be used in conjunction with a Magnetic Resonance Scanner to analyze data acquired using Blood Oxygen Level Dependent (BOLD) contrast techniques, such analysis that can be interpreted by a trained physician.

Source page: https://510kreport.com/device/K023130
Methodology: https://510kreport.com/methodology