510(k) · Cleared
ClearedClinical Phosphorus Spectroscopy Option/Magnetom Vision System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · LNI System, Nuclear Magnetic Resonance Spectroscopic
Cleared on Apr 3, 1997 after a 272-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Apr 3, 1997
- Review
- 272 days
- Class
- Class II
- Product code
- LNI
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK962627 Clinical Phosphorus Spectroscopy Option/Magnetom Vision SystemSiemens Medical Solutions USA, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK042718 13C/1H Occipital Headcoil for Magnetom AllegraSiemens Medi Cal Solutions, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK042617 31P/1H Headcoil for Magnetom AllegraSiemens Medical Solutions USA, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK080820 Tem 3002G- HN Dual Tune Head CoilMr Instruments, Inc. · 2008
Most influential descendants
Showing 3 of 3 · See all- K04271813C/1H Occipital Headcoil for Magnetom AllegraSiemens Medi Cal Solutions, Inc. · 2004 · cites it directly1descendant
- K04261731P/1H Headcoil for Magnetom AllegraSiemens Medical Solutions USA, Inc. · 2004 · cites it directly1descendant
- K080820Tem 3002G- HN Dual Tune Head CoilMr Instruments, Inc. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962627 | Clinical Phosphorus Spectroscopy Option/Magnetom Vision System | Siemens Medical Solutions USA, Inc. | 1997 | — |
| +1 | K042718 | 13C/1H Occipital Headcoil for Magnetom Allegra | Siemens Medi Cal Solutions, Inc. | 2004 | — |
| +1 | K042617 | 31P/1H Headcoil for Magnetom Allegra | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +2 | K080820 | Tem 3002G- HN Dual Tune Head Coil | Mr Instruments, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | — | Proton Spectroscopy Option for the MAGNETOM VISION Named without a submission number | |
| * | — | Spectroscopy Option for the MAGNETOM 63SP Named without a submission number |
What descends from it? (3)
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, K042718 (Siemens Medi Cal Solutions, Inc., 2004) has gone furthest, with 1 descendant 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.
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?
Siemens developed the Clinical Phosphorus Spectroscopy Option for the Magnetom Vision system to allow the non-invasive in vivo analysis of energy metabolites in muscle, liver and heart tissue. The package allows observation of phosphocreatine (PCr), inorganic phosphate (Pi), Adenosine triphosphate (ATP), phosphomonoester (PME), phosphodiester (PDE) levels. Information provided by phosphorus spectroscopy data allows evaluation of the energetic state of examined tissues and intracellular pH, measured from the chemical shift of Pi.
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/K962627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962627: Clinical Phosphorus Spectroscopy Option/Magnetom Vision System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962627
Report an extraction error
Are you the manufacturer?
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