510(k) · Cleared
ClearedMagnetic Concerto
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 Dec 21, 2000 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 248 devices in its family, counting itself, has a Class I recall. 247 later devices descend from it.
- Decided
- Dec 21, 2000
- Review
- 70 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 0
247 later devices descend from it, 6 citing it directly. 1 of the 248 devices in this family, counting this one, has a Class I recall.
- This deviceK003192 Magnetic ConcertoSiemens Medical Solutions USA, Inc. · 2000
- Descendant · cites it directly · 199 of its ownK052423 Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc. · 2006
- Descendant · 2 generations on · 180 of its ownK061964 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2006
- Descendant · 3 generations on · 178 of its ownK072728 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2008
- Descendant · 3 generations on · 177 of its ownK081734 Syngo Imaging (Version V31)Siemens AG Medical Solutions · 2008 · Recalled
- Descendant · 4 generations on · 176 of its ownK092519 Syngo.XSiemens AG Medical Solutions · 2009 · Recalled
Showing 5 of 247 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…9 generations on · 2025
Most influential descendants
Showing 5 of 247 · See all- K052423Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc. · 2006 · cites it directly199descendants
- K061964Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2006 · 2 generations on180descendants
- K072728Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2008 · 3 generations on178descendants
- K081734Syngo Imaging (Version V31)Siemens AG Medical Solutions · 2008 · 3 generations on177descendants
- K092519Syngo.XSiemens AG Medical Solutions · 2009 · 4 generations on176descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003192 | Magnetic Concerto | Siemens Medical Solutions USA, Inc. | 2000 | — |
| +1 | K052423 | Magnetom Systems with Syngo Expert - I Option | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| +2 | K061964 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2006 | — |
| +3 | K072728 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2008 | — |
| +3 | K081734 | Syngo Imaging (Version V31) | Siemens AG Medical Solutions | 2008 | 5 |
| +4 | K092519 | Syngo.X | Siemens AG Medical Solutions | 2009 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 2 | 0 |
| 2010 | 6 | 0 |
| 2011 | 10 | 0 |
| 2012 | 13 | 0 |
| 2013 | 9 | 0 |
| 2014 | 6 | 0 |
| 2015 | 13 | 0 |
| 2016 | 10 | 0 |
| 2017 | 6 | 0 |
| 2018 | 13 | 0 |
| 2019 | 15 | 0 |
| 2020 | 24 | 0 |
| 2021 | 9 | 0 |
| 2022 | 17 | 0 |
| 2023 | 20 | 0 |
| 2024 | 21 | 0 |
| 2025 | 18 | 1 |
| 2026 | 18 | 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.
1 device in this family has a Class I recall. 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? (247)
See all 2476 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K052423 (Siemens Medi Cal Solutions, Inc., 2006) has gone furthest, with 199 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/K003192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003192: Magnetic Concerto.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003192
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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