510(k) · Cleared
ClearedHitachi Stratis, MRH-1500 Magnetic Resonance Diagnostic Devices Version 6 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 Sep 5, 1996 after a 108-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Sep 5, 1996
- Review
- 108 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK961969 Hitachi Stratis, MRH-1500 Magnetic Resonance Diagnostic Devices…Hitachi Medical Systems America, Inc. · 1996
- Descendant · cites it directly · 7 of its ownK043271 R2-Mri Analysis SystemInner Vision Biometrics Pty, Ltd. · 2005
- Descendant · 2 generations on · 3 of its ownK122035 Hepafat ScanResonance Health Analysis Services Pty, Ltd. · 2013
- Descendant · 3 generations on · 2 of its ownK201039 HepaFat-AIResonance Health Analysis Services Pty, Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK213960 LiverMultiScan v5 (LMSv5)Perspectum · 2022
- Descendant · 3 generations on · 0 of its ownK253413 LiverMultiScan (v6.0)Perspectum, Ltd. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K043271R2-Mri Analysis SystemInner Vision Biometrics Pty, Ltd. · 2005 · cites it directly7descendants
- K122035Hepafat ScanResonance Health Analysis Services Pty, Ltd. · 2013 · 2 generations on3descendants
- K201039HepaFat-AIResonance Health Analysis Services Pty, Ltd. · 2020 · 3 generations on2descendants
- K213960LiverMultiScan v5 (LMSv5)Perspectum · 2022 · 2 generations on1descendant
- K253413LiverMultiScan (v6.0)Perspectum, Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961969 | Hitachi Stratis, MRH-1500 Magnetic Resonance Diagnostic Devices Version 6… | Hitachi Medical Systems America, Inc. | 1996 | — |
| +1 | K043271 | R2-Mri Analysis System | Inner Vision Biometrics Pty, Ltd. | 2005 | — |
| +2 | K122035 | Hepafat Scan | Resonance Health Analysis Services Pty, Ltd. | 2013 | — |
| +3 | K201039 | HepaFat-AI | Resonance Health Analysis Services Pty, Ltd. | 2020 | — |
| +2 | K213960 | LiverMultiScan v5 (LMSv5) | Perspectum | 2022 | — |
| +3 | K253413 | LiverMultiScan (v6.0) | Perspectum, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | — | Hitachi STRATIS with Version 3 Operating System Software Named without a submission number | |
| * | — | Hitachi MRH-1500 with Version 3 Operating System Software Named without a submission number |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043271 | R2-Mri Analysis System | 2005 | 7 |
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?
- Of its descendants, K043271 (Inner Vision Biometrics Pty, Ltd., 2005) has gone furthest, with 7 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.
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 (193 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
Imaging capabilities:
2D, 3D Spin Echo (SE)
2D Short Spin Echo (SES)
2D, 3D Fast Spin Echo (FSE)
2D Inversion Recovery (IR)
2D, 3D Fast Inversion Recovery (FIR)
2D,3D Gradient Field Echo (GFE); also with rephasing
2D, 3D Rapid Scan (RS)
MTC, RF Spoiling
MR Angiography, (2D INFA, 3D INFA, 2D GFEA, 3D GFEA, Sloped Slab Profile (SSP))
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/K961969 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961969: Hitachi Stratis, MRH-1500 Magnetic Resonance Diagnostic Devices Version 6 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/K961969
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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