510(k) Report

510(k) · Cleared

Cleared

Brainacquirerx / Brainprocessrx Data Suite Version 1.0

K061255510(k) TraditionalCleared Jun 13, 200640-day reviewClass II21 CFR 892.1000

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

Kyron Clinical Imaging, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Jun 13, 2006 as substantially equivalent to K023130 (Mri Devices Corp., 2002) and 3 other predicates after a 40-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.

Decided
Jun 13, 2006
Review
40 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K003899 (2001). 5 ancestors in all, the oldest K003573 (2001). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2001: 2 other ancestors2009: 1 descendant cleared2012: 1 descendant clearedK003899 · Ifis-SA Integrated Fuctional Imaging System · Mri Devices Corp. · 2001K023130 · Eloquence, Integrated Functional Imaging System · Mri Devices Corp. · 2002 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K023130 · Eloquence, Integrated Functional Imaging System · Mri Devices Corp. · 2002 · recalledK003899 · Ifis-SA Integrated Fuctional Imaging System · Mri Devices Corp. · 20010
  1. Root · 2 generations backK003899 Ifis-SA Integrated Fuctional Imaging SystemMri Devices Corp. · 2001
  2. 1 generation backK023130 Eloquence, Integrated Functional Imaging SystemMri Devices Corp. · 2002 · Recalled
  3. This deviceK061255 Brainacquirerx / Brainprocessrx Data Suite Version 1.0Kyron Clinical Imaging, Inc. · 2006
  4. Descendant · cites it directly · 1 of its ownK082964 Prism Acquire (Version 1.5), Prism Process (Version 1.5), Prism View…Prism Clinical Imaging, Inc. · 2009
  5. Descendant · 2 generations on · 0 of its ownK122026 Prism Acquire Prism Process Prism ViewPrism Clinical Imaging, Inc. · 2012

Most influential descendants

Showing 2 of 2 · See all
  • K082964Prism Acquire (Version 1.5), Prism Process (Version 1.5), Prism View (Version 2.5)Prism Clinical Imaging, Inc. · 2009 · cites it directly1descendant
  • K122026Prism Acquire Prism Process Prism ViewPrism Clinical Imaging, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K003899Ifis-SA Integrated Fuctional Imaging SystemMri Devices Corp.2001—
−1K023130Eloquence, Integrated Functional Imaging SystemMri Devices Corp.20021
0 (this device)K061255Brainacquirerx / Brainprocessrx Data Suite Version 1.0Kyron Clinical Imaging, Inc.2006—
+1K082964Prism Acquire (Version 1.5), Prism Process (Version 1.5), Prism View (Version…Prism Clinical Imaging, Inc.2009—
+2K122026Prism Acquire Prism Process Prism ViewPrism Clinical Imaging, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200120
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201210
FIG. 1 — Lineage of K061255, 2001–2012Source: 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
Get a 510(k) Report

What was it cleared against? (4)

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
*K023130Eloquence, Integrated Functional Imaging System
Summary page 1
…cate Devices Predicate System Manufacturer Reg. Data Eloquence Integrated MRI Devices Corp. K023130 Functional Imaging 1515 Paramount Dr. SE 10/11/2002 System Waukesha,…
Mri Devices Corp.20021
*K043290Mindstate Functional Data Acquisition Device, Version 1.0
Summary page 1
…Product code LNH Class II MindStateTM Functional Neurognostics, Inc. K043290 Data Acquisition Device 10437 Innovation Dr., Suite 309 SE 1/28/2005 (fDADTM) Milwaukee,…
Neurognostics, Inc.2005—
*K010938Syngo Multimodality Workstation
Summary page 1
…Product code LNH Class II Syngo® Multimodality Siemens Medical Systems K010938 Workstation 186 Wood Ave. South SE 6/26/2001 Iselin, NJ…
Siemens Medical Solutions USA, Inc.20015
*K003573Diffusion Tensor Imaging Option
Summary page 1
…Product code LLZ Class II Diffusion tensor imaging GE Medical Systems K003573 option for MRI P.O. Box 414, W-709 SE 1/23/2001 Milwaukee,…
Ge Medical Systems, Inc.2001—

Also cleared against K023130: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K082964Prism Acquire (Version 1.5), Prism Process (Version 1.5), Prism View (Version 2.5)Prism Clinical Imaging, Inc.20091

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
  • 2 of the 5 ancestors have a recall of any class.
  • Of its descendants, K082964 (Prism Clinical Imaging, Inc., 2009) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K023130.

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?

The BrainAcquireRx / BrainProcessRx Data Suite is software used in conjunction with a Magnetic Resonance scanner to acquire and process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRD and other MRI data sets. The BrainAcquireRx software application presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned. The patient's responses and image data from…

Read the full statement (149 words)

The BrainAcquireRx / BrainProcessRx Data Suite is software used in conjunction with a Magnetic Resonance scanner to acquire and process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRD and other MRI data sets.

The BrainAcquireRx software application presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned. The patient's responses and image data from the MRI scanner are stored for use by the BrainProcessRx application, which performs post-processing for quality control and subsequent viewing of fMRI and other data. These applications can also be used to assist in scripted data acquisition and post-processing of other anatomical, functional and physiologic MR imagery including magnetic resonance spectroscopy (MRS) and MR diffusion. The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of brain pathology and the planning and monitoring of medical treatments.

Indications for use as stated in the FDA summary.

Also cleared against K023130

1 other device cites the same predicate.

  • K052467Brain Viewrx Viewer, Version 1.0Kyron Clinical Imaging, Inc. · 2005

More from Kyron Clinical Imaging, Inc.

3 FDA decisions under this applicant name. See the company

  • K063031Prism View, ModelKyron Clinical Imaging, Inc. · 2006
  • K052467Brain Viewrx Viewer, Version 1.0Kyron Clinical Imaging, Inc. · 2005

Recent decisions in LNH

The LNH category page

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https://510kreport.com/device/K061255 · printed Nov 5, 2026

Cite this page

510(k) Report. “K061255: Brainacquirerx / Brainprocessrx Data Suite Version 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061255

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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