510(k) · Cleared
Recalled · Class II · 2021OASIS MRI System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Healthcare Americas · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Oct 21, 2020 as substantially equivalent to K192851 (Hitachi Healthcare Americas, 2020) after a 91-day review. Its family tree reaches back 5 generations to 1995. 2 later devices descend from it. It has been recalled once.
- Decided
- Oct 21, 2020
- Review
- 91 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K930265 (1995). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK930265 Hydrogen Spectroscopy Option-Probe #M1040HS/HTGE Medical Systems · 1995
- 4 generations backK991568 MR Spectroscopy PackagePhilips Medical Systems (Cleveland), Inc. · 1999
- 3 generations backK071506 Echelon Spectroscopy PackageHitachi Medical Systems America, Inc. · 2007
- 2 generations backK093044 Oasis Mri SystemHitachi Medical Systems America, Inc. · 2010 · Recalled
- 1 generation backK192851 OASIS MRI SystemHitachi Healthcare Americas · 2020
- This deviceK202030 OASIS MRI SystemHitachi Healthcare Americas · 2020
- Descendant · cites it directly · 1 of its ownK211406 OASIS MRI SystemHitachi Healthcare Americas · 2021
- Descendant · 2 generations on · 0 of its ownK240571 OASIS MRI SystemFujifilm Healthcare Corporation · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K930265 | Hydrogen Spectroscopy Option-Probe #M1040HS/HT | GE Medical Systems | 1995 | — |
| −4 | K991568 | MR Spectroscopy Package | Philips Medical Systems (Cleveland), Inc. | 1999 | — |
| −3 | K071506 | Echelon Spectroscopy Package | Hitachi Medical Systems America, Inc. | 2007 | — |
| −2 | K093044 | Oasis Mri System | Hitachi Medical Systems America, Inc. | 2010 | 1 |
| −1 | K192851 | OASIS MRI System | Hitachi Healthcare Americas | 2020 | — |
| 0 (this device) | K202030 | OASIS MRI System | Hitachi Healthcare Americas | 2020 | — |
| +1 | K211406 | OASIS MRI System | Hitachi Healthcare Americas | 2021 | — |
| +2 | K240571 | OASIS MRI System | Fujifilm Healthcare Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K192851 | OASIS MRI SystemSummary page 4…H Class II Panel Radiology Predicate Device Name Predicate Device(s): OASIS MRI System (K192851) Regulation Number: 21 CFR 892.1000 Regulation Name: System, Nuclear Magnetic Resonance I… | 2020 |
| † | K073310 | Oasis CTL Coil, OD Flexible Body Coil (L and XL), and Rapid Foot Coil | 2008 |
| † | K080062 | Oasis Rapid Breast Coil, Model MR-Ibc-120 and Oasis Rapid NV Coil, Model MR-NVC-120 | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211406 | OASIS MRI System | 2021 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 29, 2021 | Class II | Z-2339-2021 | Vendor change control | There was no label on the pad packaging or notification in the user manual that the table pads contained dry natural rubber which is required by the Code of Federal Regulations section 21CFR801.437. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K211406 (Hitachi Healthcare Americas, 2021) has gone furthest, with 1 descendant 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. 2020, 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 (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: 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/K202030 · printed Nov 3, 2026
Cite this page
510(k) Report. “K202030: OASIS MRI System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K202030
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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