510(k) · Cleared
ClearedGE Propeller Imaging Option for Mri
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on May 2, 2003 as substantially equivalent to K972990 (GE Medical Systems, 1998) and 1 other predicate after a 14-day review. Its family tree reaches back 2 generations to 1997. 3 later devices descend from it.
- Decided
- May 2, 2003
- Review
- 14 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K971055 (1997). 3 ancestors in all, the oldest K944979 (1995). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK971055 Diffusion Weighted MR Imaging /Magnetom VisionSiemens Medical Solutions USA, Inc. · 1997
- 1 generation backK972990 Magnetic Resonance Diagnostic SystemGE Medical Systems · 1998
- This deviceK031230 GE Propeller Imaging Option for MriGE Medical Systems · 2003
- Descendant · cites it directly · 1 of its ownK113394 Mavric SLGe Medical Systems, LLC · 2012
- Descendant · 2 generations on · 0 of its ownK143253 O-MARPhilips Medical Systems Nederland B.V. · 2015
- Descendant · cites it directly · 0 of its ownK073081 Jet Software for Excelart Vantage Atlas-Z and Atlas-XToshiba America Medical Systems, In.C · 2007
Most influential descendants
Showing 3 of 3 · See all- K113394Mavric SLGe Medical Systems, LLC · 2012 · cites it directly1descendant
- K143253O-MARPhilips Medical Systems Nederland B.V. · 2015 · 2 generations on0descendants
- K073081Jet Software for Excelart Vantage Atlas-Z and Atlas-XToshiba America Medical Systems, In.C · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971055 | Diffusion Weighted MR Imaging /Magnetom Vision | Siemens Medical Solutions USA, Inc. | 1997 | — |
| −1 | K972990 | Magnetic Resonance Diagnostic System | GE Medical Systems | 1998 | — |
| 0 (this device) | K031230 | GE Propeller Imaging Option for Mri | GE Medical Systems | 2003 | — |
| +1 | K113394 | Mavric SL | Ge Medical Systems, LLC | 2012 | — |
| +2 | K143253 | O-MAR | Philips Medical Systems Nederland B.V. | 2015 | — |
| +1 | K073081 | Jet Software for Excelart Vantage Atlas-Z and Atlas-X | Toshiba America Medical Systems, In.C | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
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 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K972990 | Magnetic Resonance Diagnostic SystemSummary page 2…e The Propeller Imaging Option is substantially equivalent to the features currently marketed GE Medical System Diffusion Weighted EPI Imaging Option (510k #K972990),and Echo Planar Imaging Option including FSE (K944979). 0 Summary of Studies The Propeller Imaging Option was evaluated… | 1998 |
| * | K944979 | Magnetic Resonance Diagnostic AccessorySummary page 2…uivalent to the features currently marketed GE Medical System Diffusion Weighted EPI Imaging Option (510k #K972990),and Echo Planar Imaging Option including FSE (K944979). 0 Summary of Studies The Propeller Imaging Option was evaluated to thelEC60601-1-4, the Programmable Electrical Med… | 1995 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K113394 (Ge Medical Systems, LLC, 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
Propeller Imaging Option is a Fast Spin Echo (FSE) based sequence which employs a alternate k-space trajectory. 1. When used with diffUsionsensitizing gradients on a minimum of 3 axes, it will augment the standard Echo Planar Imaging (EPI) based difision imaging by providing improved image quality in areas of high susceptibility. This may aid the trained physician in the visualization of pathology in areas traditionally obscured by susceptibility…
Read the full statement (207 words)
Propeller Imaging Option is a Fast Spin Echo (FSE) based sequence which employs a alternate k-space trajectory.
1. When used with diffUsionsensitizing gradients on a minimum of 3 axes, it will augment the standard Echo Planar Imaging (EPI) based difision imaging by providing improved image quality in areas of high susceptibility. This may aid the trained physician in the visualization of pathology in areas traditionally obscured by susceptibility artifacts.
It is intended for use in anatomical regions where significant susceptibility differences exist between adjacent structures (e.g. tissue/air and tissuei’bone). This includes, but is not limited to, inferior brain areas such as cerebellum, internal auditory canal, vertebrae and orthopedic areas. Other high susceptibility regions include tissue in the presence of MRI compatible metallic implants, artificial joint, etc.
2. When used in the place of high resolution FSE, it will yield improved contrast-to-noise and signal-to-noise with comparable resolution and overall scan time, or improved contrast-to-noise and signal-to-noise with minimal in-plane motion-induced artifact. This may aid the trained physician in visualization of areas with reduced signal and image contrast or areas obscured by motion artifacts.
It is intended for use in high-resolution anatomical regions where FSE is traditionally used, particularly in neurological imaging, where improved contrast-to-noise and signal-to-noise is needed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031230 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031230: GE Propeller Imaging Option for Mri.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031230
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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