510(k) Report

510(k) · Cleared

Cleared

Trillium Oval V 5.1 MRI System

K160152510(k) TraditionalCleared May 20, 2016119-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

Hitachi Medical Systems America, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on May 20, 2016 as substantially equivalent to K142734 (Hitachi Medical Systems America, Inc., 2015) after a 119-day review. Its family tree reaches back 9 generations to 1995.

Decided
May 20, 2016
Review
119 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
1

Its longest line of descent runs back 9 generations to K955249 (1995). 10 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestorReference device: K151015 · ECHELON Oval V 5.0 MRI System · Hitachi Medical Systems America, Inc. · 2015 · recalledK955249 · Sensor Pad · Inventive Products, Inc. · 1995K973450 · Sensor Pad · Inventive Products, Inc. · 1997K991469 · Aware Pad · Aac Consulting Group, Inc. · 1999K023390 · MY Breast Friend, Breast Self-Exam Pad · Mbf Sales, LLC · 2002K050602 · Altaire · Hitachi Medical Systems America, Inc. · 2005K052172 · HHF1 Magnetic Resonance Imaging System · Hitachi Medical Systems America, Inc. · 2005 · recalledK083533 · Echelon C Mri System · Hitachi Medical Systems America, Inc. · 2009 · recalledK113145 · Echelon Oval Mri System · Hitachi Medical Systems America, Inc. · 2012 · recalledK142734 · TRILLIUM Oval MR System · Hitachi Medical Systems America, Inc. · 201519952000200520102015
Other ancestors, by generation 6 generations back: 1 other ancestor K142734 · TRILLIUM Oval MR System · Hitachi Medical Systems America, Inc. · 2015K113145 · Echelon Oval Mri System · Hitachi Medical Systems America, Inc. · 2012 · recalledK083533 · Echelon C Mri System · Hitachi Medical Systems America, Inc. · 2009 · recalledK052172 · HHF1 Magnetic Resonance Imaging System · Hitachi Medical Systems America, Inc. · 2005 · recalledK050602 · Altaire · Hitachi Medical Systems America, Inc. · 2005K023390 · MY Breast Friend, Breast Self-Exam Pad · Mbf Sales, LLC · 2002K991469 · Aware Pad · Aac Consulting Group, Inc. · 1999K973450 · Sensor Pad · Inventive Products, Inc. · 1997K955249 · Sensor Pad · Inventive Products, Inc. · 1995−50
  1. Root · 9 generations backK955249 Sensor PadInventive Products, Inc. · 1995
  2. 5 generations between
  3. 3 generations backK083533 Echelon C Mri SystemHitachi Medical Systems America, Inc. · 2009 · Recalled
  4. 2 generations backK113145 Echelon Oval Mri SystemHitachi Medical Systems America, Inc. · 2012 · Recalled
  5. 1 generation backK142734 TRILLIUM Oval MR SystemHitachi Medical Systems America, Inc. · 2015
  6. This deviceK160152 Trillium Oval V 5.1 MRI SystemHitachi Medical Systems America, Inc. · 2016
Show all 9 generations
  1. Root · 9 generations backK955249 Sensor PadInventive Products, Inc. · 1995
  2. 8 generations backK973450 Sensor PadInventive Products, Inc. · 1997
  3. 7 generations backK991469 Aware PadAac Consulting Group, Inc. · 1999
  4. 6 generations backK023390 MY Breast Friend, Breast Self-Exam PadMbf Sales, LLC · 2002
  5. 5 generations backK050602 AltaireHitachi Medical Systems America, Inc. · 2005
  6. 4 generations backK052172 HHF1 Magnetic Resonance Imaging SystemHitachi Medical Systems America, Inc. · 2005 · Recalled
  7. 3 generations backK083533 Echelon C Mri SystemHitachi Medical Systems America, Inc. · 2009 · Recalled
  8. 2 generations backK113145 Echelon Oval Mri SystemHitachi Medical Systems America, Inc. · 2012 · Recalled
  9. 1 generation backK142734 TRILLIUM Oval MR SystemHitachi Medical Systems America, Inc. · 2015
  10. This deviceK160152 Trillium Oval V 5.1 MRI SystemHitachi Medical Systems America, Inc. · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K955249Sensor PadInventive Products, Inc.1995—
−8K973450Sensor PadInventive Products, Inc.1997—
−7K991469Aware PadAac Consulting Group, Inc.1999—
−6K023390MY Breast Friend, Breast Self-Exam PadMbf Sales, LLC2002—
−5K050602AltaireHitachi Medical Systems America, Inc.2005—
−4K052172HHF1 Magnetic Resonance Imaging SystemHitachi Medical Systems America, Inc.20053
−3K083533Echelon C Mri SystemHitachi Medical Systems America, Inc.20092
−2K113145Echelon Oval Mri SystemHitachi Medical Systems America, Inc.20123
−1K142734TRILLIUM Oval MR SystemHitachi Medical Systems America, Inc.2015—
0 (this device)K160152Trillium Oval V 5.1 MRI SystemHitachi Medical Systems America, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
FIG. 1 — Lineage of K160152, 1995–2016Source: 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
*K142734TRILLIUM Oval MR System
Summary page 5
…l Radiology Trade/Proprietary Name: TRILLIUM Oval V5.1 MRI System Predicate Device(s): TRILLIUM Oval MRI System (K142734) Device Intended Use The TRILLIUM Oval System is an imaging device and is intended to provide the physician with physiological a…
Hitachi Medical Systems America, Inc.2015—
†K151015ECHELON Oval V 5.0 MRI SystemHitachi Medical Systems America, Inc.20151

Also cleared against K142734: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 21 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
  • 4 of the 10 ancestors have a recall of any class.
  • 1 other device also cites its predicate K142734.

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. 2016, this device’s year, is highlighted.

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 TRILLIUM Oval MRI System is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons…

Read the full statement (136 words)

The TRILLIUM Oval MRI System is an imaging device, and is intended to provide the physician with physiological and

clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces

transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head,

body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei)

exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice

relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images

provide information that can be useful in diagnosis determination.

Anatomical Region: Head, Body, Spine, Extremities

Nucleus excited: Proton

Diagnostic uses: T1, T2, proton density weighted imaging

Diffusion weighted imaging

MR Angiography

Image processing

Spectroscopy

Whole Body

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K142734

1 other device cites the same predicate.

  • K162079TRILLIUM Oval Head Coil 32Hitachi Medical Systems America, Inc. · 2016

More from Hitachi Medical Systems America, Inc.

100 FDA decisions under this applicant name. See the company

  • K163528HITACHI Supria Whole-body X-ray CT System Phase 3Hitachi Medical Systems America, Inc. · 2017
  • K162079TRILLIUM Oval Head Coil 32Hitachi Medical Systems America, Inc. · 2016
  • K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc. · 2016
  • K153547ECHELON Oval V 5.1 MRI SystemHitachi Medical Systems America, Inc. · 20162 recalls
  • K150595SCENARIA Phase 3 Whole-body X-ray CT SystemHitachi Medical Systems America, Inc. · 20152 recalls

Recent decisions in LNH

The LNH category page

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  • K261612SwiftSight-BodyCompositionAirs Medical, Inc. · 2026
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https://510kreport.com/device/K160152 · printed Nov 4, 2026

Cite this page

510(k) Report. “K160152: Trillium Oval V 5.1 MRI System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160152

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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