510(k) Report

510(k) · Cleared

Cleared

Trex Mri Magnetic Resonance Diagnostic Device

K982157510(k) TraditionalCleared Sep 2, 199875-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

Field Effects · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Sep 2, 1998 as substantially equivalent to K963953 (Imig-Mri Systems, LLC, 1996) after a 75-day review. Its family tree reaches back 1 generation to 1996.

Decided
Sep 2, 1998
Review
75 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K963953 (1996). No later device cites it as a predicate yet.

K963953 · Imig-Mri · Imig-Mri Systems, LLC · 1996199619982000
K963953 · Imig-Mri · Imig-Mri Systems, LLC · 19960
  1. Root · 1 generation backK963953 Imig-MriImig-Mri Systems, LLC · 1996
  2. This deviceK982157 Trex Mri Magnetic Resonance Diagnostic DeviceField Effects · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K963953Imig-MriImig-Mri Systems, LLC1996—
0 (this device)K982157Trex Mri Magnetic Resonance Diagnostic DeviceField Effects1998—
FIG. 1 — Lineage of K982157, 1996–1998Source: 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
*K963953Imig-Mri
Summary page 2
…NH 90MOS (Magnetic Resonance Specialty Coil) Trade/Proprietary Name: TREX MRI Predicate Device: IMIG-MRI DEVICE DESCRIPTION: FUNCTION Identical to the IMIG-MRI 510(k) K963953. As a result of newly created business arrangements, the original IMiG-MRI system will now be renamed as TREX MRI. With the excep…
Imig-Mri Systems, LLC1996—

Also cleared against K963953: 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?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K963953.

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 TREX MRI system produces cross-sectional images: Anatomical Region: General body anatomy, including head, spine, torso, and extremities Nucleus excited: ¹H nuclei (Proton) Diagnostic uses: Images correspond to the distribution of ¹H nuclei exhibiting nuclear magnetic resonance, with image intensity dependent upon NMR parameters, including - spin-lattice relaxation time (T1) - spin-spin relaxation time (T2) - density of nuclei (ρ) - flow velocity -…

Read the full statement (142 words)

The TREX MRI system produces cross-sectional images:

Anatomical Region: General body anatomy, including head, spine, torso, and extremities

Nucleus excited: ¹H nuclei (Proton)

Diagnostic uses: Images correspond to the distribution of ¹H nuclei exhibiting nuclear magnetic resonance, with image intensity dependent upon NMR parameters, including

- spin-lattice relaxation time (T1)

- spin-spin relaxation time (T2)

- density of nuclei (ρ)

- flow velocity

- chemical shift (δ)

Clinical use: Images may be interpreted by a trained physician to yield information that can be useful in the determination of a diagnosis.

RF Coils:

Head - quadrature

Cervical Spine - quadrature

Lumbar Spine, Thoracic Spine, and Abdomen - quadrature

Knee - linear

Image Acquisition

Spin Echo

Gradient Echo (GE, RGE)

Fast Spin Echo (FSE)

Fast Dual Echo (FDE)

3D Fast Gradient Echo (3DGE, 3DRGE)

Inversion Recovery with Fast Spin Echo (FSE STIR, FSE FLAIR)

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 K963953

1 other device cites the same predicate.

  • K983902Field Effects Mri SystemIntermagnetics General Corp. · 1999

Recent decisions in LNH

The LNH category page

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

https://510kreport.com/device/K982157 · printed Nov 5, 2026

Cite this page

510(k) Report. “K982157: Trex Mri Magnetic Resonance Diagnostic Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982157

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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