510(k) · Cleared
Recalled · Class II · 2015Echelon Oval Mri System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Medical Systems America, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on May 1, 2012 as substantially equivalent to K083533 (Hitachi Medical Systems America, Inc., 2009) after a 189-day review. Its family tree reaches back 7 generations to 1995. 10 later devices descend from it. It has been recalled 3 times.
- Decided
- May 1, 2012
- Review
- 189 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 7 generations to K955249 (1995). 8 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK955249 Sensor PadInventive Products, Inc. · 1995
- 6 generations backK973450 Sensor PadInventive Products, Inc. · 1997
- 5 generations backK991469 Aware PadAac Consulting Group, Inc. · 1999
- 4 generations backK023390 MY Breast Friend, Breast Self-Exam PadMbf Sales, LLC · 2002
- 3 generations backK050602 AltaireHitachi Medical Systems America, Inc. · 2005
- 2 generations backK052172 HHF1 Magnetic Resonance Imaging SystemHitachi Medical Systems America, Inc. · 2005 · Recalled
- 1 generation backK083533 Echelon C Mri SystemHitachi Medical Systems America, Inc. · 2009 · Recalled
- This deviceK113145 Echelon Oval Mri SystemHitachi Medical Systems America, Inc. · 2012
- Descendant · cites it directly · 6 of its ownK151015 ECHELON Oval V 5.0 MRI SystemHitachi Medical Systems America, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 5 of its ownK153547 ECHELON Oval V 5.1 MRI SystemHitachi Medical Systems America, Inc. · 2016 · Recalled
- Descendant · 3 generations on · 4 of its ownK172110 ECHELON OVAL V6.0A MRI SystemHitachi Healthcare Americas Corporation · 2018 · Recalled
- Descendant · 4 generations on · 3 of its ownK223426 ECHELON Synergy MRI systemFujifilm Healthcare Corporation · 2023
- Descendant · 5 generations on · 2 of its ownK233687 ECHELON Synergy V10.0FUJIFILM Healthcare Americas Corporation · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K151015ECHELON Oval V 5.0 MRI SystemHitachi Medical Systems America, Inc. · 2015 · cites it directly6descendants
- K153547ECHELON Oval V 5.1 MRI SystemHitachi Medical Systems America, Inc. · 2016 · 2 generations on5descendants
- K172110ECHELON OVAL V6.0A MRI SystemHitachi Healthcare Americas Corporation · 2018 · 3 generations on4descendants
- K223426ECHELON Synergy MRI systemFujifilm Healthcare Corporation · 2023 · 4 generations on3descendants
- K233687ECHELON Synergy V10.0FUJIFILM Healthcare Americas Corporation · 2024 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K955249 | Sensor Pad | Inventive Products, Inc. | 1995 | — |
| −6 | K973450 | Sensor Pad | Inventive Products, Inc. | 1997 | — |
| −5 | K991469 | Aware Pad | Aac Consulting Group, Inc. | 1999 | — |
| −4 | K023390 | MY Breast Friend, Breast Self-Exam Pad | Mbf Sales, LLC | 2002 | — |
| −3 | K050602 | Altaire | Hitachi Medical Systems America, Inc. | 2005 | — |
| −2 | K052172 | HHF1 Magnetic Resonance Imaging System | Hitachi Medical Systems America, Inc. | 2005 | 3 |
| −1 | K083533 | Echelon C Mri System | Hitachi Medical Systems America, Inc. | 2009 | 2 |
| 0 (this device) | K113145 | Echelon Oval Mri System | Hitachi Medical Systems America, Inc. | 2012 | — |
| +1 | K151015 | ECHELON Oval V 5.0 MRI System | Hitachi Medical Systems America, Inc. | 2015 | 1 |
| +2 | K153547 | ECHELON Oval V 5.1 MRI System | Hitachi Medical Systems America, Inc. | 2016 | 2 |
| +3 | K172110 | ECHELON OVAL V6.0A MRI System | Hitachi Healthcare Americas Corporation | 2018 | 1 |
| +4 | K223426 | ECHELON Synergy MRI system | Fujifilm Healthcare Corporation | 2023 | — |
| +5 | K233687 | ECHELON Synergy V10.0 | FUJIFILM Healthcare Americas Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K083533 | Echelon C Mri SystemSummary page 1…umber: 9OLNH Trade/Proprietary Name: ECHELON Oval MRI System Predicate Device(s): ECHELON C Magnetic Resonance Imaging System (K083533) Device Intended Use The ECHELON Oval System is an imaging device and is intended to provide the physician with physiological an… | 2009 |
What descends from it? (10)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 16, 2015 | Class II | Z-1541-2017 | Software in the Use Environment | Image data transferred from the MRI system to a workstation showed errors on the slice position reference image. |
| Aug 18, 2014 | Class II | Z-2564-2014 | Device Design | The Gradient Coil was found to have a failure mode that allowed it to overheat and become a burn hazard. |
| Jan 31, 2013 | Class II | Z-1559-2013 | Software design | Hitachi discovered a software error that can occur when simultaneously scanning a patient while processing images previously acquired from a different patient. The software error can occur randomly. The error causes an image in the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K151015 (Hitachi Medical Systems America, Inc., 2015) has gone furthest, with 6 descendants 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. 2012, this device’s year, is highlighted.
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?
The ECHELON 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 ECHELON 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 (TI), 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: TI, T2, proton density weighted imaging
Diffusion weighted imaging
MR Angiography
Image processing
Spectroscopy
Whole Body
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113145 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113145: Echelon Oval Mri System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113145
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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