510(k) · Cleared
ClearedOASIS MRI System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Healthcare Corporation · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Apr 12, 2024 as substantially equivalent to K211406 (Hitachi Healthcare Americas, 2021) after a 43-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Apr 12, 2024
- Review
- 43 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K930265 (1995). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK930265 Hydrogen Spectroscopy Option-Probe #M1040HS/HTGE Medical Systems · 1995
- 6 generations backK991568 MR Spectroscopy PackagePhilips Medical Systems (Cleveland), Inc. · 1999
- 5 generations backK071506 Echelon Spectroscopy PackageHitachi Medical Systems America, Inc. · 2007
- 4 generations backK093044 Oasis Mri SystemHitachi Medical Systems America, Inc. · 2010 · Recalled
- 3 generations backK192851 OASIS MRI SystemHitachi Healthcare Americas · 2020
- 2 generations backK202030 OASIS MRI SystemHitachi Healthcare Americas · 2020 · Recalled
- 1 generation backK211406 OASIS MRI SystemHitachi Healthcare Americas · 2021
- This deviceK240571 OASIS MRI SystemFujifilm Healthcare Corporation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K930265 | Hydrogen Spectroscopy Option-Probe #M1040HS/HT | GE Medical Systems | 1995 | — |
| −6 | K991568 | MR Spectroscopy Package | Philips Medical Systems (Cleveland), Inc. | 1999 | — |
| −5 | K071506 | Echelon Spectroscopy Package | Hitachi Medical Systems America, Inc. | 2007 | — |
| −4 | K093044 | Oasis Mri System | Hitachi Medical Systems America, Inc. | 2010 | 1 |
| −3 | K192851 | OASIS MRI System | Hitachi Healthcare Americas | 2020 | — |
| −2 | K202030 | OASIS MRI System | Hitachi Healthcare Americas | 2020 | 1 |
| −1 | K211406 | OASIS MRI System | Hitachi Healthcare Americas | 2021 | — |
| 0 (this device) | K240571 | OASIS MRI System | Fujifilm Healthcare Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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.
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 29 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 8 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. 2024, 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 OASIS 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…
Read the full statement (135 words)
The OASIS 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: T1, 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/K240571 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240571: OASIS MRI System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240571
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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