510(k) · Cleared
ClearedMagnetom Systems - I-Class and T-Class Releases
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 Nov 3, 2006 as substantially equivalent to K032428 (Siemens Medical Solutions USA, Inc., 2003) and 4 other predicates after a 73-day review. Its family tree reaches back 4 generations to 1997. 22 of the 317 devices in its family, counting itself, have a Class I recall. 308 later devices descend from it.
- Decided
- Nov 3, 2006
- Review
- 73 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K971684 (1997). 8 ancestors in all. 308 later devices descend from it, 3 citing it directly. 22 of the 317 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 3 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 2 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 1 generation backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- This deviceK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- Descendant · cites it directly · 300 of its ownK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- Descendant · cites it directly · 229 of its ownK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- Descendant · cites it directly · 228 of its ownK071925 Magnetom EssenzaSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 224 of its ownK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- Descendant · 2 generations on · 222 of its ownK083166 Specialty Coils for the Magnetom EssenzaSiemens Medical Solutions USA, Inc. · 2009
Showing 5 of 308 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 308 · See all- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · cites it directly300descendants
- K082427Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008 · cites it directly229descendants
- K071925Magnetom EssenzaSiemens Medical Solutions USA, Inc. · 2007 · cites it directly228descendants
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 2 generations on224descendants
- K083166Specialty Coils for the Magnetom EssenzaSiemens Medical Solutions USA, Inc. · 2009 · 2 generations on222descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −3 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −2 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −1 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| 0 (this device) | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| +1 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| +1 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| +1 | K071925 | Magnetom Essenza | Siemens Medical Solutions USA, Inc. | 2007 | 1 |
| +2 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
| +2 | K083166 | Specialty Coils for the Magnetom Essenza | Siemens Medical Solutions USA, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 1 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 1 |
| 2011 | 6 | 0 |
| 2012 | 8 | 2 |
| 2013 | 18 | 2 |
| 2014 | 9 | 0 |
| 2015 | 12 | 1 |
| 2016 | 9 | 1 |
| 2017 | 20 | 1 |
| 2018 | 21 | 2 |
| 2019 | 25 | 1 |
| 2020 | 28 | 3 |
| 2021 | 12 | 1 |
| 2022 | 29 | 2 |
| 2023 | 32 | 3 |
| 2024 | 21 | 0 |
| 2025 | 24 | 1 |
| 2026 | 23 | 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.
22 devices in this family have 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? (5)
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 2…System FDA Clearance FDA Clearance Date Number MAGN ETOM Avanto K032428 October 16, 2003 MAGNETOM Espree K041112 July 21, 2004 MAGNETOM Sqniph… | 2003 |
| * | K041112 | Magnetom Espree SystemSummary page 2…Number MAGN ETOM Avanto K032428 October 16, 2003 MAGNETOM Espree K041112 July 21, 2004 MAGNETOM Sqniphony a Tfim SystemAGNTOMSymhon a im K050199 Februar… | 2004 |
| * | K050199 | Magnetom Symphony a Tim SystemSummary page 2…October 16, 2003 MAGNETOM Espree K041112 July 21, 2004 MAGNETOM Sqniphony a Tfim SystemAGNTOMSymhon a im K050199 February I8, 2005 System MAGNETOM Trio a Tim System K050200 February 28, 2005 Si… | 2005 |
| * | K050200 | Magnetom Trio a Tim SystemSummary page 2…ly 21, 2004 MAGNETOM Sqniphony a Tfim SystemAGNTOMSymhon a im K050199 February I8, 2005 System MAGNETOM Trio a Tim System K050200 February 28, 2005 Siemens Medical Solutions, Inc.. intends to onIfecr a software and hardware upgradeLS'ngo MR… | 2005 |
| * | K052164 | Magnetom Systems with Software Syngo MR 2006ASummary page 3…MAGNETOM Trio a Tim Syst0 Ferury 28, 2005 with software platformn syngo MR 2006A that was described in premarket notificationl K052 164 that received FDA clearance on October 4, 2005. General Safety and Effectiveness Concerns: Thie introduction of the MAGNEIKTOM… | 2005 |
What descends from it? (308)
See all 3083 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (22 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.
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K130885Magnetom Avanto-Fit, Magnetom Skyra-FitSiemens Medical Solutions USA, Inc. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K121160Magnetom SpectraSiemens Medical Solutions USA, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 12 Class I recalls
- K181613MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11DSiemens Medical Solutions USA, Inc. · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
- K132119Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medical Solutions USA, Inc. · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 12 Class I recalls
- K200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc. · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K173592MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM AvantofitSiemens Medical Solutions USA, Inc. · 2018 · 5 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
Nearest 12 of 22 shown.
Nearest 5 of 22; all are on the web page.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 8 ancestors have a recall of any class.
- Of its descendants, K072237 (Siemens Medical Solutions USA, Inc., 2007) has gone furthest, with 300 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 MAGNETOM Systems - I-class and T-class releases are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display 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 safe biopsy needles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062454 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062454: Magnetom Systems - I-Class and T-Class Releases.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062454
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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