510(k) · Cleared
ClearedMagnetom Systems with Syngo Expert - I Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medi Cal Solutions, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jan 13, 2006 as substantially equivalent to K032428 (Siemens Medical Solutions USA, Inc., 2003) and 8 other predicates after a 133-day review. Its family tree reaches back 3 generations to 1997. 1 of the 209 devices in its family, counting itself, has a Class I recall. 199 later devices descend from it.
- Decided
- Jan 13, 2006
- Review
- 133 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 3 generations to K971684 (1997). 9 ancestors in all, the oldest K970852 (1997). 199 later devices descend from it, 6 citing it directly. 1 of the 209 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 2 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 1 generation backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- This deviceK052423 Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc. · 2006
- Descendant · cites it directly · 180 of its ownK061964 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2006
- Descendant · 2 generations on · 178 of its ownK072728 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2008
- Descendant · 2 generations on · 177 of its ownK081734 Syngo Imaging (Version V31)Siemens AG Medical Solutions · 2008 · Recalled
- Descendant · 3 generations on · 176 of its ownK092519 Syngo.XSiemens AG Medical Solutions · 2009 · Recalled
- Descendant · 4 generations on · 99 of its ownK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
Showing 5 of 199 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…8 generations on · 2025
Most influential descendants
Showing 5 of 199 · See all- K061964Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2006 · cites it directly180descendants
- K072728Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2008 · 2 generations on178descendants
- K081734Syngo Imaging (Version V31)Siemens AG Medical Solutions · 2008 · 2 generations on177descendants
- K092519Syngo.XSiemens AG Medical Solutions · 2009 · 3 generations on176descendants
- K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011 · 4 generations on99descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −2 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −1 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| 0 (this device) | K052423 | Magnetom Systems with Syngo Expert - I Option | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| +1 | K061964 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2006 | — |
| +2 | K072728 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2008 | — |
| +2 | K081734 | Syngo Imaging (Version V31) | Siemens AG Medical Solutions | 2008 | 5 |
| +3 | K092519 | Syngo.X | Siemens AG Medical Solutions | 2009 | 4 |
| +4 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 7 | 0 |
| 2014 | 6 | 0 |
| 2015 | 9 | 0 |
| 2016 | 7 | 0 |
| 2017 | 6 | 0 |
| 2018 | 13 | 0 |
| 2019 | 11 | 0 |
| 2020 | 24 | 0 |
| 2021 | 9 | 0 |
| 2022 | 16 | 0 |
| 2023 | 19 | 0 |
| 2024 | 19 | 0 |
| 2025 | 18 | 1 |
| 2026 | 15 | 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.
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? (9)
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 |
|---|---|---|---|
| * | K032428 | Magnetom Avanto MR SystemSummary page 3…me ea FDA Clearance Date Number MAGNETOM 1.5 T Avanto K032428 October 16, 2003 MAGNETOM 1.5 T Espree K041112 July 21, 2004 M… | 2003 |
| * | K041112 | Magnetom Espree SystemSummary page 3…Number MAGNETOM 1.5 T Avanto K032428 October 16, 2003 MAGNETOM 1.5 T Espree K041112 July 21, 2004 MAGNETOM 1.5 T Symphony a K050199 eruary Tim System… | 2004 |
| * | K050199 | Magnetom Symphony a Tim SystemSummary page 3…October 16, 2003 MAGNETOM 1.5 T Espree K041112 July 21, 2004 MAGNETOM 1.5 T Symphony a K050199 eruary Tim System MAGNETOM 3.0 T Trio a Tim s stem ~~~~~K050200… | 2005 |
| * | K050200 | Magnetom Trio a Tim SystemSummary page 3…GNETOM 1.5 T Symphony a K050199 eruary Tim System MAGNETOM 3.0 T Trio a Tim s stem ~~~~~K050200 February 28, 2005 MAGNETOM 1.0 T Harmony K970852 June 5, 1997 MAGNETOM… | 2005 |
| * | K970852 | Magnetom Project 024 System (Numaris 3.5 Software)Summary page 3…tem MAGNETOM 3.0 T Trio a Tim s stem ~~~~~K050200 February 28, 2005 MAGNETOM 1.0 T Harmony K970852 June 5, 1997 MAGNETOM 1.5 T Symphony K971684 August 5, 1997 MAGNETO… | 1997 |
| * | K971684 | Magnetom Project 047 System (Numaris 3.5 Software)Summary page 3…0200 February 28, 2005 MAGNETOM 1.0 T Harmony K970852 June 5, 1997 MAGNETOM 1.5 T Symphony K971684 August 5, 1997 MAGNETOM 1.5 T Sonata K993731 December 23, 1999 MA… | 1997 |
| * | K993731 | Sonata Gradients/Magnetom Symphony SystemSummary page 3…852 June 5, 1997 MAGNETOM 1.5 T Symphony K971684 August 5, 1997 MAGNETOM 1.5 T Sonata K993731 December 23, 1999 MAGNETOM 0.2 T Concerto K003192 December 21, 2000… | 1999 |
| * | K003192 | Magnetic ConcertoSummary page 3…August 5, 1997 MAGNETOM 1.5 T Sonata K993731 December 23, 1999 MAGNETOM 0.2 T Concerto K003192 December 21, 2000 MAGNETOM 3.0 T Trio KO] 3586 December 28, 2001.… | 2000 |
| * | K013586 | Magnetom Trio SystemSummary page 6…MAGNETOM 1.5 T Sonata K993731 MAGNETOM 0_2 T Concerto K003192 MAGNETOM 3.0 T Trio K013586 The above listed MAGNETOM systems are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transvers… | 2001 |
What descends from it? (199)
See all 1996 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 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 7 of the 9 ancestors have a recall of any class.
- Of its descendants, K061964 (Siemens AG Medical Solutions, 2006) has gone furthest, with 180 descendants of its own.
- 10 other devices also cite its predicate K032428.
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 | — |
What is it indicated for?
The above listed MAGNETOM systems are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. These images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis. They may also be used for…
Read the full statement (152 words)
The above listed MAGNETOM systems are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. These images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.
They may also be used for imaging during interventional procedures performed with MR compatible devices such as, in room display and MR safe biopsy needles.
The syngo Expert-i feature allows the local user of the MRI (e.g. tech) to get help and assistance from other personnel of the radiology department (e.g. other tech or physician) to perform scans faster and with better quality. For this purpose, a remote user within the local network of the MRI (i.e. the network of the radiology) can log onto the MR main or satellite console.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052423 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052423: Magnetom Systems with Syngo Expert - I Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052423
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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