510(k) · Cleared
ClearedClinical Proton Spectroscopy Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Nov 14, 1995 after a 218-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Nov 14, 1995
- Review
- 218 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK951650 Clinical Proton Spectroscopy OptionSiemens Medical Solutions USA, Inc. · 1995
- Descendant · cites it directly · 6 of its ownK991568 MR Spectroscopy PackagePhilips Medical Systems (Cleveland), Inc. · 1999
- Descendant · 2 generations on · 5 of its ownK071506 Echelon Spectroscopy PackageHitachi Medical Systems America, Inc. · 2007
- Descendant · 3 generations on · 4 of its ownK093044 Oasis Mri SystemHitachi Medical Systems America, Inc. · 2010 · Recalled
- Descendant · 4 generations on · 3 of its ownK192851 OASIS MRI SystemHitachi Healthcare Americas · 2020
- Descendant · 5 generations on · 2 of its ownK202030 OASIS MRI SystemHitachi Healthcare Americas · 2020 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K991568MR Spectroscopy PackagePhilips Medical Systems (Cleveland), Inc. · 1999 · cites it directly6descendants
- K071506Echelon Spectroscopy PackageHitachi Medical Systems America, Inc. · 2007 · 2 generations on5descendants
- K093044Oasis Mri SystemHitachi Medical Systems America, Inc. · 2010 · 3 generations on4descendants
- K192851OASIS MRI SystemHitachi Healthcare Americas · 2020 · 4 generations on3descendants
- K202030OASIS MRI SystemHitachi Healthcare Americas · 2020 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951650 | Clinical Proton Spectroscopy Option | Siemens Medical Solutions USA, Inc. | 1995 | — |
| +1 | K991568 | MR Spectroscopy Package | Philips Medical Systems (Cleveland), Inc. | 1999 | — |
| +2 | K071506 | Echelon Spectroscopy Package | Hitachi Medical Systems America, Inc. | 2007 | — |
| +3 | K093044 | Oasis Mri System | Hitachi Medical Systems America, Inc. | 2010 | 1 |
| +4 | K192851 | OASIS MRI System | Hitachi Healthcare Americas | 2020 | — |
| +5 | K202030 | OASIS MRI System | Hitachi Healthcare Americas | 2020 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K991568 (Philips Medical Systems (Cleveland), Inc., 1999) has gone furthest, with 6 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 | — |
https://510kreport.com/device/K951650 · printed Nov 5, 2026
Cite this page
510(k) Report. “K951650: Clinical Proton Spectroscopy Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K951650
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026