510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Eloquence, Integrated Functional Imaging System

K023130510(k) SpecialCleared Oct 11, 200221-day reviewClass II21 CFR 892.1000Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mri Devices Corp. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Oct 11, 2002 as substantially equivalent to K003899 (Mri Devices Corp., 2001) after a 21-day review. Its family tree reaches back 1 generation to 2001. 7 later devices descend from it. It has been recalled once.

Decided
Oct 11, 2002
Review
21 days
Class
Class II
Product code
LNH
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K003899 (2001). 7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2006: 3 descendants cleared2005: 1 descendant cleared2009: 1 descendant cleared2014: 1 descendant cleared2012: 1 descendant clearedK003899 · Ifis-SA Integrated Fuctional Imaging System · Mri Devices Corp. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants K003899 · Ifis-SA Integrated Fuctional Imaging System · Mri Devices Corp. · 20010
  1. Root · 1 generation backK003899 Ifis-SA Integrated Fuctional Imaging SystemMri Devices Corp. · 2001
  2. This deviceK023130 Eloquence, Integrated Functional Imaging SystemMri Devices Corp. · 2002
  3. Descendant · cites it directly · 5 of its ownK052467 Brain Viewrx Viewer, Version 1.0Kyron Clinical Imaging, Inc. · 2005
  4. Descendant · 2 generations on · 2 of its ownK063031 Prism View, ModelKyron Clinical Imaging, Inc. · 2006
  5. Descendant · cites it directly · 2 of its ownK061255 Brainacquirerx / Brainprocessrx Data Suite Version 1.0Kyron Clinical Imaging, Inc. · 2006
  6. Descendant · 2 generations on · 1 of its ownK082964 Prism Acquire (Version 1.5), Prism Process (Version 1.5), Prism View…Prism Clinical Imaging, Inc. · 2009
  7. Descendant · 2 generations on · 1 of its ownK060453 Aze VirtualplaceAze, Ltd. · 2006

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2005: 12006: 32009: 12012: 12014: 1
2005high 3 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 7 · See all
  • K052467Brain Viewrx Viewer, Version 1.0Kyron Clinical Imaging, Inc. · 2005 · cites it directly5descendants
  • K063031Prism View, ModelKyron Clinical Imaging, Inc. · 2006 · 2 generations on2descendants
  • K061255Brainacquirerx / Brainprocessrx Data Suite Version 1.0Kyron Clinical Imaging, Inc. · 2006 · cites it directly2descendants
  • K082964Prism Acquire (Version 1.5), Prism Process (Version 1.5), Prism View (Version 2.5)Prism Clinical Imaging, Inc. · 2009 · 2 generations on1descendant
  • K060453Aze VirtualplaceAze, Ltd. · 2006 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003899Ifis-SA Integrated Fuctional Imaging SystemMri Devices Corp.2001—
0 (this device)K023130Eloquence, Integrated Functional Imaging SystemMri Devices Corp.2002—
+1K052467Brain Viewrx Viewer, Version 1.0Kyron Clinical Imaging, Inc.2005—
+2K063031Prism View, ModelKyron Clinical Imaging, Inc.2006—
+1K061255Brainacquirerx / Brainprocessrx Data Suite Version 1.0Kyron Clinical Imaging, Inc.2006—
+2K082964Prism Acquire (Version 1.5), Prism Process (Version 1.5), Prism View (Version…Prism Clinical Imaging, Inc.2009—
+2K060453Aze VirtualplaceAze, Ltd.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200630
200910
201210
201410
FIG. 1 — Lineage of K023130, 2001–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LNH device

  1. #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K003899Ifis-SA Integrated Fuctional Imaging SystemMri Devices Corp.2001—

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K052467Brain Viewrx Viewer, Version 1.0Kyron Clinical Imaging, Inc.20055
K061255Brainacquirerx / Brainprocessrx Data Suite Version 1.0Kyron Clinical Imaging, Inc.20062

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 6, 2020Class IIZ-1440-2020Component change controlInsufficient shielding of Philips SensaVue DVI Adapter for computer monitor.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K052467 (Kyron Clinical Imaging, Inc., 2005) has gone furthest, with 5 descendants of its own.

How does its category compare?

All LNH devices

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNH

26in 2025

2007: 122008: 192009: 172010: 122011: 162012: 222013: 192014: 172015: 192016: 202017: 182018: 292019: 262020: 322021: 272022: 302023: 302024: 262025: 262026 (partial year): 24
2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007: 35 days median2008: 53 days median2009: 70 days median2010: 94 days median2011: 81 days median2012: 89 days median2013: 108 days median2014: 108 days median2015: 140 days median2016: 108 days median2017: 98 days median2018: 128 days median2019: 62 days median2020: 121 days median2021: 87 days median2022: 74 days median2023: 124 days median2024: 104 days median2025: 122 days median2026 (partial year): 126 days median
2007high 140 (2015) · low 35 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LNH

8in 2025

2007: 252008: 122009: 72010: 172011: 112012: 52013: 22014: 132015: 12, 2 Class I2016: 12018: 712019: 52020: 42021: 412022: 132023: 10, 1 Class I2024: 42025: 8, 5 Class I2026 (partial year): 43
2007high 71 (2018) · low 0 (2017)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · LNH

1,263in 2025

2007: 1142008: 1672009: 1942010: 1652011: 1822012: 1702013: 1072014: 1192015: 1132016: 1352017: 1212018: 1582019: 1582020: 982021: 842022: 1382023: 1592024: 2812025: 1,263
2007high 1,263 (2025) · low 84 (2021)2025

MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007123525114
2008195312167
200917707194
2010129417165
2011168111182
201222895170
2013191082107
20141710813119
20151914012 (2)113
2016201081135
201718980121
20182912871158
201926625158
202032121498
202127874184
2022307413138
20233012410 (1)159
2024261044281
2025261228 (5)1,263
20262412643—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

More from Mri Devices Corp.

71 FDA decisions under this applicant name. See the company

  • K041286Dynacad V1.0Mri Devices Corp. · 2004
  • K041481Model BBC-127 Biopsy Breast CoilMri Devices Corp. · 20041 recall
  • K040349Modification to HRW-127 Wrist Array CoilMri Devices Corp. · 2004
  • K040348Modification to HNC-127-Int Neurovascular Array CoilMri Devices Corp. · 2004
  • K040288QSC-127-Int Shoulder Array Coil SetMri Devices Corp. · 2004

Recent decisions in LNH

The LNH category page

  • K262902ECHELON SynergyFujifilm Corporation · 2026
  • K260092Vista AI ScanVista AI, Inc. · 2026
  • K261612SwiftSight-BodyCompositionAirs Medical, Inc. · 2026
  • K261283APERTO Lucent MRI SystemFujifilm Corporation · 2026
  • K261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd. · 2026

https://510kreport.com/device/K023130 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023130: Eloquence, Integrated Functional Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023130

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026