510(k) · Cleared
Recalled · Class I · 2025Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio
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 5, 2012 as substantially equivalent to K111242 (Siemens Medical Solutions USA, Inc., 2011) and 3 other predicates after a 175-day review. Its family tree reaches back 9 generations to 1997. 21 of the 247 devices in its family, counting itself, have a Class I recall. 215 later devices descend from it. It has been recalled 3 times, including 2 Class I recalls.
- Decided
- Nov 5, 2012
- Review
- 175 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 3 (2 Class I)
- Predicates
- 4
Its longest line of descent runs back 9 generations to K971684 (1997). 31 ancestors in all, the oldest K932271 (1994). 215 later devices descend from it, 16 citing it directly. 21 of the 247 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 5 generations between
- 3 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 2 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- 1 generation backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- This deviceK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012
- Descendant · cites it directly · 115 of its ownK141977 Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with…Siemens Medical Solutions USA, Inc. · 2014
- Descendant · 2 generations on · 85 of its ownK151579 MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit…Siemens Medical Solutions USA, Inc. · 2015 · Recalled (Class I)
- Descendant · 2 generations on · 84 of its ownK153343 MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · Recalled (Class I)
- Descendant · cites it directly · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- Descendant · cites it directly · 54 of its ownK130749 Syngo.MR General; Syngo.MR Cardiology; Syngo.MR VascularSiemens Medical Solutions USA, Inc. · 2013
Show all 9 generations
- Root · 9 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 8 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 7 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 6 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 5 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 4 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 3 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 2 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- 1 generation backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- This deviceK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012
Showing 5 of 215 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 215 · See all- K141977Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A…Siemens Medical Solutions USA, Inc. · 2014 · cites it directly115descendants
- K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma…Siemens Medical Solutions USA, Inc. · 2015 · 2 generations on85descendants
- K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · 2 generations on84descendants
- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · cites it directly63descendants
- K130749Syngo.MR General; Syngo.MR Cardiology; Syngo.MR VascularSiemens Medical Solutions USA, Inc. · 2013 · cites it directly54descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −8 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −7 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −6 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −5 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −4 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −3 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −2 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
| −1 | K111242 | Magnetom Aera and Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| 0 (this device) | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | Siemens Medi Cal Solutions, Inc. | 2012 | — |
| +1 | K141977 | Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo… | Siemens Medical Solutions USA, Inc. | 2014 | — |
| +2 | K151579 | MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM… | Siemens Medical Solutions USA, Inc. | 2015 | Class I |
| +2 | K153343 | MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit | Siemens Medi Cal Solutions, Inc. | 2016 | Class I |
| +1 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| +1 | K130749 | Syngo.MR General; Syngo.MR Cardiology; Syngo.MR Vascular | Siemens Medical Solutions USA, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 11 | 2 |
| 2014 | 7 | 0 |
| 2015 | 7 | 1 |
| 2016 | 5 | 1 |
| 2017 | 15 | 1 |
| 2018 | 18 | 2 |
| 2019 | 19 | 1 |
| 2020 | 21 | 3 |
| 2021 | 9 | 1 |
| 2022 | 21 | 2 |
| 2023 | 25 | 3 |
| 2024 | 18 | 0 |
| 2025 | 20 | 1 |
| 2026 | 19 | 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.
21 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? (8)
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 |
|---|---|---|---|
| * | K111242 | Magnetom Aera and Magnetom SkyraSummary page 4…PrdcaeDeieNae Mauacue Number Date MAGNETOM Aera & Siemens 1 MAGNETOM Skyra with Medical Ki111242 November 23, 2011 syn go® MR D1l1 Solutions MAGNETOM Avanto & Siemens 2 MAGNETOM Veri… | 2011 |
| * | K082427 | Syngo MR B17Summary page 4…Ki111242 November 23, 2011 syn go® MR D1l1 Solutions MAGNETOM Avanto & Siemens 2 MAGNETOM Verio with Medical K082427 November 7, 2008 syngo®MR, B817 Solutions 3 MR-Touch ~GEMedical K032… | 2008 |
| * | K091114 | TXRX 1.5T CP Head Coil; TXRX 3T CP Head CoilSummary page 4…Knee Coils ElEcrDnmc)023 2008 TxRx 1.5T & 3T CP Head Quality 6 Coils Electrodynamics K091114 May 1, 2009 (QED) ________ 7 Sentinelle Endo Coil… | 2009 |
| * | K103274 | Sentinelle Endo Coil Array for Pelvic ImagingSummary page 4…rodynamics K091114 May 1, 2009 (QED) ________ 7 Sentinelle Endo Coil MediallIn K103274 August 18, 2011 8 Sentinelle l6ch Breast Sentinelle K122 Aust5,01 8 Coil… | 2011 |
| * | — | MR-Touch Named without a submission number | |
| * | — | 3D ASL Named without a submission number | |
| * | — | TxRx 1.5T & 3T 15ch Knee Coils Named without a submission number | |
| * | — | Sentinelle 16ch Breast Coil Named without a submission number |
What descends from it? (215)
See all 21516 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141977 | Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A… | 2014 | 115 |
| K123920 | Syngo.Via | 2013 | 63 |
| K130749 | Syngo.MR General; Syngo.MR Cardiology; Syngo.MR Vascular | 2013 | 54 |
| K123938 | Syngo MR B19 for Magnetom Avanto, Syngo MR B19 for Magnetom Espree, Syngo MR B19 for… | 2013 | 38 |
| K152602 | Olea Sphere V3.0 | 2016 | 17 |
| K123510 | Magnetom Skyra | 2013 | 16 |
| K163234 | Biograph mMR with syngo MR E11P system software | 2017 | 12 |
| K130262 | Magnetom Essenza with Syngo MR D14 | 2013 | 11 |
| K132951 | Magnetom Aera | 2013 | 9 |
| K140666 | MR Elastography | 2014 | 2 |
Has anything in its family been recalled? (21 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 28, 2025 | Class I | Z-2666-2025 | Under Investigation by firm | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within… |
| Aug 28, 2025 | Class I | Z-2665-2025 | Under Investigation by firm | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within… |
| Mar 9, 2015 | Class II | Z-1308-2015 | Nonconforming Material/Component | The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that gradient outputs could exceed IEC60601-2-33 limits and peripheral nerve stimulation could occur. |
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.
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K181613MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11DSiemens Medical Solutions USA, Inc. · 2018 · Cites it directly · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
- K130885Magnetom Avanto-Fit, Magnetom Skyra-FitSiemens Medical Solutions USA, Inc. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K132119Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc. · 2013 · 2 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 · 2 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 · 2 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 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2017 · 3 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 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 4 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
- K183244MAGNETOM LuminaSiemens Medical Solutions USA, Inc. · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
Nearest 12 of 20 shown.
Nearest 5 of 20; all are on the web page.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 13 of the 31 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K141977 (Siemens Medical Solutions USA, Inc., 2014) has gone furthest, with 115 descendants of its own.
- 1 other device also cites its predicate K111242.
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. 2012, this device’s year, is highlighted.
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 described above 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. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may…
Read the full statement (122 words)
The MAGNETOM systems described above 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.
Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.
The MAGNETOM systems described above may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-safe biopsy needles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121434 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121434: Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121434
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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