510(k) · Cleared
ClearedECHELON Synergy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Corporation · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Sep 17, 2025 as substantially equivalent to K241429 (Fujifilm Healthcare Corporation, 2024) after a 135-day review. Its family tree reaches back 14 generations to 1995.
- Decided
- Sep 17, 2025
- Review
- 135 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K955249 (1995). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 14 generations backK955249 Sensor PadInventive Products, Inc. · 1995
- 10 generations between
- 3 generations backK223426 ECHELON Synergy MRI systemFujifilm Healthcare Corporation · 2023
- 2 generations backK233687 ECHELON Synergy V10.0FUJIFILM Healthcare Americas Corporation · 2024
- 1 generation backK241429 ECHELON Synergy MRI SystemFujifilm Healthcare Corporation · 2024
- This deviceK251386 ECHELON SynergyFujifilm Corporation · 2025
Show all 14 generations
- Root · 14 generations backK955249 Sensor PadInventive Products, Inc. · 1995
- 13 generations backK973450 Sensor PadInventive Products, Inc. · 1997
- 12 generations backK991469 Aware PadAac Consulting Group, Inc. · 1999
- 11 generations backK023390 MY Breast Friend, Breast Self-Exam PadMbf Sales, LLC · 2002
- 10 generations backK050602 AltaireHitachi Medical Systems America, Inc. · 2005
- 9 generations backK052172 HHF1 Magnetic Resonance Imaging SystemHitachi Medical Systems America, Inc. · 2005 · Recalled
- 8 generations backK083533 Echelon C Mri SystemHitachi Medical Systems America, Inc. · 2009 · Recalled
- 7 generations backK113145 Echelon Oval Mri SystemHitachi Medical Systems America, Inc. · 2012 · Recalled
- 6 generations backK151015 ECHELON Oval V 5.0 MRI SystemHitachi Medical Systems America, Inc. · 2015 · Recalled
- 5 generations backK153547 ECHELON Oval V 5.1 MRI SystemHitachi Medical Systems America, Inc. · 2016 · Recalled
- 4 generations backK172110 ECHELON OVAL V6.0A MRI SystemHitachi Healthcare Americas Corporation · 2018 · Recalled
- 3 generations backK223426 ECHELON Synergy MRI systemFujifilm Healthcare Corporation · 2023
- 2 generations backK233687 ECHELON Synergy V10.0FUJIFILM Healthcare Americas Corporation · 2024
- 1 generation backK241429 ECHELON Synergy MRI SystemFujifilm Healthcare Corporation · 2024
- This deviceK251386 ECHELON SynergyFujifilm Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K955249 | Sensor Pad | Inventive Products, Inc. | 1995 | — |
| −13 | K973450 | Sensor Pad | Inventive Products, Inc. | 1997 | — |
| −12 | K991469 | Aware Pad | Aac Consulting Group, Inc. | 1999 | — |
| −11 | K023390 | MY Breast Friend, Breast Self-Exam Pad | Mbf Sales, LLC | 2002 | — |
| −10 | K050602 | Altaire | Hitachi Medical Systems America, Inc. | 2005 | — |
| −9 | K052172 | HHF1 Magnetic Resonance Imaging System | Hitachi Medical Systems America, Inc. | 2005 | 3 |
| −8 | K083533 | Echelon C Mri System | Hitachi Medical Systems America, Inc. | 2009 | 2 |
| −7 | K113145 | Echelon Oval Mri System | Hitachi Medical Systems America, Inc. | 2012 | 3 |
| −6 | K151015 | ECHELON Oval V 5.0 MRI System | Hitachi Medical Systems America, Inc. | 2015 | 1 |
| −5 | K153547 | ECHELON Oval V 5.1 MRI System | Hitachi Medical Systems America, Inc. | 2016 | 2 |
| −4 | K172110 | ECHELON OVAL V6.0A MRI System | Hitachi Healthcare Americas Corporation | 2018 | 1 |
| −3 | K223426 | ECHELON Synergy MRI system | Fujifilm Healthcare Corporation | 2023 | — |
| −2 | K233687 | ECHELON Synergy V10.0 | FUJIFILM Healthcare Americas Corporation | 2024 | — |
| −1 | K241429 | ECHELON Synergy MRI System | Fujifilm Healthcare Corporation | 2024 | — |
| 0 (this device) | K251386 | ECHELON Synergy | Fujifilm Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K241429 | ECHELON Synergy MRI SystemSummary page 6…LNH Class 2 Panel Radiology Predicate Device Name Predicate Device(s): ECHELON Synergy MRI System (K241429) Regulation Number: 21 CFR 892.1000 Regulation Name: System, Nuclear Magnetic Resonance Imaging Product… | 2024 |
| † | K152330 | Expression MR400 MRI Patient Monitoring System | 2015 |
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?
- The line of descent spans 30 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 7 of the 15 ancestors have a recall of any class.
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. 2025, 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 Synergy 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 (142 words)
The ECHELON Synergy 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 (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.
Anatomical Region: Head, Body, Spine, Extremities
Nucleus excited: Proton
Diagnostic uses:
• Tl, 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/K251386 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251386: ECHELON Synergy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251386
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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