510(k) Report

510(k) · Cleared

Cleared

Aurora

K032082510(k) SpecialCleared Jul 30, 200323-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 Jul 30, 2003 as substantially equivalent to K012154 (Aurora Imaging Technology, Inc., 2001) after a 23-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.

Decided
Jul 30, 2003
Review
23 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K012154 (2001). 3 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2008: 1 descendant cleared2003: 1 descendant clearedK012154 · Aurora Magnetic Resonance Diagnostic Device · Aurora Imaging Technology, Inc. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants K012154 · Aurora Magnetic Resonance Diagnostic Device · Aurora Imaging Technology, Inc. · 20010
  1. Root · 1 generation backK012154 Aurora Magnetic Resonance Diagnostic DeviceAurora Imaging Technology, Inc. · 2001
  2. This deviceK032082 AuroraAurora Imaging Technology, Inc. · 2003
  3. Descendant · cites it directly · 0 of its ownK073425 Modification to Aurora Mri SystemAurora Imaging Technology, Inc. · 2008
  4. Descendant · cites it directly · 0 of its ownK052698 Modification to: AuroraAurora Imaging Technology, Inc. · 2005
  5. Descendant · cites it directly · 0 of its ownK032678 Modification to: AuroraAurora Imaging Technology, Inc. · 2003

Most influential descendants

Showing 3 of 3 · See all
  • K073425Modification to Aurora Mri SystemAurora Imaging Technology, Inc. · 2008 · cites it directly0descendants
  • K052698Modification to: AuroraAurora Imaging Technology, Inc. · 2005 · cites it directly0descendants
  • K032678Modification to: AuroraAurora Imaging Technology, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200810
FIG. 1 — Lineage of K032082, 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.

TypeNumberDeviceApplicantDecidedRecalls
*K012154Aurora Magnetic Resonance Diagnostic DeviceAurora Imaging Technology, Inc.2001—

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K073425Modification to Aurora Mri SystemAurora Imaging Technology, Inc.20080
K052698Modification to: AuroraAurora Imaging Technology, Inc.20050
K032678Modification to: AuroraAurora Imaging Technology, Inc.20030

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.
  • Of its descendants, K073425 (Aurora Imaging Technology, Inc., 2008) has gone furthest, with 0 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 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, 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 MX system reflect the spatial…

Read the full statement (182 words)

The AURORA 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, 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 MX 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 (Tl), spin-spin relaxation time (T2), 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 MRI 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

TI, T2, proton density measurements

Image processing

Imaging capabilities: 2D Spin Echo (SE)

2D/3D Gradient Echo (GRE)

Fat Suppression

Imaging processing: Image Subtraction

Image Filtering

Indications for use as stated in the FDA summary.

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
  • K023686Aurora MR-Guided Interventional SystemAurora Imaging Technology, Inc. · 2003
  • K012154Aurora Magnetic Resonance Diagnostic DeviceAurora Imaging Technology, Inc. · 2001

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/K032082 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032082: Aurora.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032082

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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