510(k) Report

510(k) · Cleared

Cleared

Aurora Magnetic Resonance Diagnostic Device

K012154510(k) TraditionalCleared Sep 19, 200170-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

Aurora Imaging Technology, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Sep 19, 2001 after a 70-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 4 later devices descend from it.

Decided
Sep 19, 2001
Review
70 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
1

4 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 2 descendants cleared2005: 1 descendant cleared2008: 1 descendant cleared200020052010201520202025
  1. This deviceK012154 Aurora Magnetic Resonance Diagnostic DeviceAurora Imaging Technology, Inc. · 2001
  2. Descendant · cites it directly · 3 of its ownK032082 AuroraAurora Imaging Technology, Inc. · 2003
  3. Descendant · 2 generations on · 0 of its ownK073425 Modification to Aurora Mri SystemAurora Imaging Technology, Inc. · 2008
  4. Descendant · 2 generations on · 0 of its ownK052698 Modification to: AuroraAurora Imaging Technology, Inc. · 2005
  5. Descendant · 2 generations on · 0 of its ownK032678 Modification to: AuroraAurora Imaging Technology, Inc. · 2003

Most influential descendants

Showing 4 of 4 · See all
  • K032082AuroraAurora Imaging Technology, Inc. · 2003 · cites it directly3descendants
  • K073425Modification to Aurora Mri SystemAurora Imaging Technology, Inc. · 2008 · 2 generations on0descendants
  • K052698Modification to: AuroraAurora Imaging Technology, Inc. · 2005 · 2 generations on0descendants
  • K032678Modification to: AuroraAurora Imaging Technology, Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K012154Aurora Magnetic Resonance Diagnostic DeviceAurora Imaging Technology, Inc.2001—
+1K032082AuroraAurora Imaging Technology, Inc.2003—
+2K073425Modification to Aurora Mri SystemAurora Imaging Technology, Inc.2008—
+2K052698Modification to: AuroraAurora Imaging Technology, Inc.2005—
+2K032678Modification to: AuroraAurora Imaging Technology, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200510
200810
FIG. 1 — Lineage of K012154, 2001–2008Source: 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK000356FDA’s K000356 is C.T.M. Mobility Scooter, Model H2-686, HS-740, HS-580
Our OCR of the scanned summary read K000356, FDA’s number for C.T.M. Mobility Scooter, Model H2-686, HS-740, HS-580 (Warepalmy Enterprise, LLC (Usa)). Its FDA name has none of the distinctive words the summary uses for the device it names, “AURORA”. Kept off the family tree.
Warepalmy Enterprise, LLC (Usa)2000—

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K032082AuroraAurora Imaging Technology, Inc.20033

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?

  • Of its descendants, K032082 (Aurora Imaging Technology, Inc., 2003) has gone furthest, with 3 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?

The AURORA MR 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, and oblique cross-sectional images that display the internal structure of the extremities (breast tissue, axilla, and chest wall local to the breast). The images produced by the MR system reflect the spatial…

Read the full statement (186 words)

The AURORA MR 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, and oblique cross-sectional images that display the internal structure of the

extremities (breast tissue, axilla, and chest wall local to the breast). 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 (12), and flow. When interpreted by a trained physician, these images

provide information that can be useful in diagnosis determination.

The AURORA is a dedicated breast MRl system intended to be used as an adjunct to

conventional breast screening methods.

® Anatomical Region: Breast tissue, axilla, and chest wall local to the breast

® Nucleus excited: Proton

® Diagnostic uses: 2D,3D T1- / T2-weighted imaging

1, 72, proton density measurements

image processing

® Imaging capabilities: 2D Spin Echo (SE)

2D/3D Gradient Echo (GRE)

Fat Suppression

® Imaging processing: Image Subtraction

Imoge Filtering

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

More from Aurora Imaging Technology, Inc.

7 FDA decisions under this applicant name. See the company

  • K073425Modification to Aurora Mri SystemAurora Imaging Technology, Inc. · 2008
  • K052698Modification to: AuroraAurora Imaging Technology, Inc. · 2005
  • K032678Modification to: AuroraAurora Imaging Technology, Inc. · 2003
  • K032082AuroraAurora Imaging Technology, Inc. · 2003
  • K023686Aurora MR-Guided Interventional SystemAurora Imaging Technology, Inc. · 2003

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https://510kreport.com/device/K012154 · printed Nov 3, 2026

Cite this page

510(k) Report. “K012154: Aurora Magnetic Resonance Diagnostic Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K012154

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026