510(k) · Cleared
ClearedMagnetic Resonance Diagnostic Device, Version 5.0 Operating System Software
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 Jan 25, 1999 as substantially equivalent to K971279 (Hitachi Medical Systems America, Inc., 1997) after a 56-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Jan 25, 1999
- Review
- 56 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971279 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK971279 Version 4 Operating System SoftwareHitachi Medical Systems America, Inc. · 1997
- This deviceK984274 Magnetic Resonance Diagnostic Device, Version 5.0 Operating System…Hitachi Medical Systems America, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971279 | Version 4 Operating System Software | Hitachi Medical Systems America, Inc. | 1997 | — |
| 0 (this device) | K984274 | Magnetic Resonance Diagnostic Device, Version 5.0 Operating System Software | Hitachi Medical Systems America, Inc. | 1999 | — |
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 |
|---|---|---|---|
| * | K971279 | Version 4 Operating System SoftwareSummary page 2…hi MRP-7000 with Version 4.0 Operating System Software DEVICE DESCRIPTION: FUNCTION Identical to the AIRIS and MRP-7000 with Version 4.0 Operating System software (Cf. K971279), and the AIRIS and MRP-7000 with Version 4.0D Operating System software as described in a memo-to-file document, dated September… | 1997 |
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?
- Its one ancestor has no recall.
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?
The 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, 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)…
Read the full statement (212 words)
The 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, 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 (T1), 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: 2D T1- / T2-weighted imaging
T1, T2, proton density measurements
MR Angiography
image processing
Imaging capabilities:
2D, 3D Spin Echo (SE)
2D Inversion Recovery (IR)
2D, 3D Fast Spin Echo (FSE), Fast Inversion Recovery (FIR)
2D,3D Gradient Field Echo (GE); also with rephasing (GR)
2D Steady state acquisition with rewinded GE (SARGE)
3D Steady state acquisition with rewinded GE (SARGE); also with rephasing
2D Dual Slice acquisition (DS)
MR Angiography (2D TOF, 3D TOF, half echo, high resolution/high definition, sloped slab profile, on- and off-resoance magnetization transfer contrast)
RF Coil Uniformity
Adaptive Image post-processing
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984274: Magnetic Resonance Diagnostic Device, Version 5.0 Operating System Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984274
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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