510(k) · Cleared
ClearedMR Spectroscopy Package
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · LNI System, Nuclear Magnetic Resonance Spectroscopic
Cleared on Jul 19, 1999 as substantially equivalent to K930265 (GE Medical Systems, 1995) and 1 other predicate after a 75-day review. Its family tree reaches back 1 generation to 1995. 6 later devices descend from it.
- Decided
- Jul 19, 1999
- Review
- 75 days
- Class
- Class II
- Product code
- LNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K930265 (1995). 2 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK930265 Hydrogen Spectroscopy Option-Probe #M1040HS/HTGE Medical Systems · 1995
- This deviceK991568 MR Spectroscopy PackagePhilips Medical Systems (Cleveland), Inc. · 1999
- Descendant · cites it directly · 5 of its ownK071506 Echelon Spectroscopy PackageHitachi Medical Systems America, Inc. · 2007
- Descendant · 2 generations on · 4 of its ownK093044 Oasis Mri SystemHitachi Medical Systems America, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 3 of its ownK192851 OASIS MRI SystemHitachi Healthcare Americas · 2020
- Descendant · 4 generations on · 2 of its ownK202030 OASIS MRI SystemHitachi Healthcare Americas · 2020 · Recalled
- Descendant · 5 generations on · 1 of its ownK211406 OASIS MRI SystemHitachi Healthcare Americas · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K071506Echelon Spectroscopy PackageHitachi Medical Systems America, Inc. · 2007 · cites it directly5descendants
- K093044Oasis Mri SystemHitachi Medical Systems America, Inc. · 2010 · 2 generations on4descendants
- K192851OASIS MRI SystemHitachi Healthcare Americas · 2020 · 3 generations on3descendants
- K202030OASIS MRI SystemHitachi Healthcare Americas · 2020 · 4 generations on2descendants
- K211406OASIS MRI SystemHitachi Healthcare Americas · 2021 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930265 | Hydrogen Spectroscopy Option-Probe #M1040HS/HT | GE Medical Systems | 1995 | — |
| 0 (this device) | K991568 | MR Spectroscopy Package | Philips Medical Systems (Cleveland), Inc. | 1999 | — |
| +1 | K071506 | Echelon Spectroscopy Package | Hitachi Medical Systems America, Inc. | 2007 | — |
| +2 | K093044 | Oasis Mri System | Hitachi Medical Systems America, Inc. | 2010 | 1 |
| +3 | K192851 | OASIS MRI System | Hitachi Healthcare Americas | 2020 | — |
| +4 | K202030 | OASIS MRI System | Hitachi Healthcare Americas | 2020 | 1 |
| +5 | K211406 | OASIS MRI System | Hitachi Healthcare Americas | 2021 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K930265 | Hydrogen Spectroscopy Option-Probe #M1040HS/HTSummary page 2…table has been created to demonstrate their substantial equivalence. SUBSTANTIAL EQUIVALENCE TABLE Picker MR Predicate Devices: GE Probe Parameter Spectroscopy Option (K930265), Siemens (K951650) Nucleus Same. Proton. (Both predicates) Type of Spectroscopy | Same. Single Voxel and Chemical Shift Imaging.… | 1995 |
| * | K951650 | Clinical Proton Spectroscopy OptionSummary page 2…ted to demonstrate their substantial equivalence. SUBSTANTIAL EQUIVALENCE TABLE Picker MR Predicate Devices: GE Probe Parameter Spectroscopy Option (K930265), Siemens (K951650) Nucleus Same. Proton. (Both predicates) Type of Spectroscopy | Same. Single Voxel and Chemical Shift Imaging. (See K951650) Spec… | 1995 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071506 | Echelon Spectroscopy Package | 2007 | 5 |
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?
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.
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 Picker MR Spectroscopy Package is intended for use as a non-invasive diagnostic device that provides information based on relative concentrations 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 (T1), 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 making a diagnosis.
This package is indicated for use as follows:
Anatomical region: Head, whole body
Nuclei Excited: 'H
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/K991568 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991568: MR Spectroscopy Package.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991568
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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