510(k) · Cleared
Recalled · Class II · 2018Oasis Mri System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Medical Systems America, Inc. · LNI System, Nuclear Magnetic Resonance Spectroscopic
Cleared on Mar 16, 2010 as substantially equivalent to K071506 (Hitachi Medical Systems America, Inc., 2007) after a 167-day review. Its family tree reaches back 3 generations to 1995. 4 later devices descend from it. It has been recalled once.
- Decided
- Mar 16, 2010
- Review
- 167 days
- Class
- Class II
- Product code
- LNI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K930265 (1995). 4 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK930265 Hydrogen Spectroscopy Option-Probe #M1040HS/HTGE Medical Systems · 1995
- 2 generations backK991568 MR Spectroscopy PackagePhilips Medical Systems (Cleveland), Inc. · 1999
- 1 generation backK071506 Echelon Spectroscopy PackageHitachi Medical Systems America, Inc. · 2007
- This deviceK093044 Oasis Mri SystemHitachi Medical Systems America, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK192851 OASIS MRI SystemHitachi Healthcare Americas · 2020
- Descendant · 2 generations on · 2 of its ownK202030 OASIS MRI SystemHitachi Healthcare Americas · 2020 · Recalled
- Descendant · 3 generations on · 1 of its ownK211406 OASIS MRI SystemHitachi Healthcare Americas · 2021
- Descendant · 4 generations on · 0 of its ownK240571 OASIS MRI SystemFujifilm Healthcare Corporation · 2024
Most influential descendants
Showing 4 of 4 · See all- K192851OASIS MRI SystemHitachi Healthcare Americas · 2020 · cites it directly3descendants
- K202030OASIS MRI SystemHitachi Healthcare Americas · 2020 · 2 generations on2descendants
- K211406OASIS MRI SystemHitachi Healthcare Americas · 2021 · 3 generations on1descendant
- K240571OASIS MRI SystemFujifilm Healthcare Corporation · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930265 | Hydrogen Spectroscopy Option-Probe #M1040HS/HT | GE Medical Systems | 1995 | — |
| −2 | K991568 | MR Spectroscopy Package | Philips Medical Systems (Cleveland), Inc. | 1999 | — |
| −1 | K071506 | Echelon Spectroscopy Package | Hitachi Medical Systems America, Inc. | 2007 | — |
| 0 (this device) | K093044 | Oasis Mri System | Hitachi Medical Systems America, Inc. | 2010 | — |
| +1 | K192851 | OASIS MRI System | Hitachi Healthcare Americas | 2020 | — |
| +2 | K202030 | OASIS MRI System | Hitachi Healthcare Americas | 2020 | 1 |
| +3 | K211406 | OASIS MRI System | Hitachi Healthcare Americas | 2021 | — |
| +4 | 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 |
|---|---|---|
| 2020 | 2 | 0 |
| 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 LNI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192851 | OASIS MRI System | 2020 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 18, 2018 | Class II | Z-2479-2018 | Device Design | The stainless steel belt which runs the length of the table underneath the tabletop is exposed when the tabletop is extended into the magnet for scanning. The firm has received two complaints where technologists have cut their fingers on… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K192851 (Hitachi Healthcare Americas, 2020) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LNI devicesLNI System, Nuclear Magnetic Resonance Spectroscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LNI
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · LNI
Too few LNI 510(k)s in any year since 2007 to give a median.
Recalls per year · LNI
12in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LNI
1in 2025
MAUDE reports naming product code LNI, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 4 | 1 |
| 2024 | 0 | — | 12 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Hitachi Oasis MRI with spectroscopy is intended for use as a non-invasive diagnostic device that provides information based on relative concentration of metabolites in body tissues. This NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (Ti), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide…
Read the full statement (102 words)
The Hitachi Oasis MRI with spectroscopy is intended for use as a non-invasive diagnostic device that provides information based on relative concentration of metabolites in body tissues. This NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (Ti), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in diagnosis determination.
Anatomical Region: Head, body, spine, extremities
Nucleus excited: proton
Diagnostic uses: Ti, 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/K093044 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093044: Oasis Mri System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093044
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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