510(k) · Cleared
Recalled · Class II · 2019Magnetom Aera and Magnetom Skyra
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 Nov 23, 2011 as substantially equivalent to K101347 (Siemens Medical Solutions USA, Inc., 2010) and 5 other predicates after a 204-day review. Its family tree reaches back 8 generations to 1997. 21 of the 243 devices in its family, counting itself, have a Class I recall. 220 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 23, 2011
- Review
- 204 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 3
- Predicates
- 6
Its longest line of descent runs back 8 generations to K971684 (1997). 22 ancestors in all. 220 later devices descend from it, 2 citing it directly. 21 of the 243 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 7 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 6 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 5 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 4 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 3 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 2 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 1 generation backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- This deviceK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011
- Descendant · cites it directly · 215 of its ownK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- Descendant · 2 generations on · 115 of its ownK141977 Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with…Siemens Medical Solutions USA, Inc. · 2014
- Descendant · 3 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 · 3 generations on · 84 of its ownK153343 MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · Recalled (Class I)
- Descendant · 2 generations on · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
Showing 5 of 220 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 220 · See all- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · cites it directly215descendants
- K141977Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A…Siemens Medical Solutions USA, Inc. · 2014 · 2 generations on115descendants
- K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma…Siemens Medical Solutions USA, Inc. · 2015 · 3 generations on85descendants
- K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · 3 generations on84descendants
- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · 2 generations on63descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −7 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −6 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −5 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −4 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −3 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −2 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −1 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
| 0 (this device) | K111242 | Magnetom Aera and Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2011 | — |
| +1 | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | Siemens Medi Cal Solutions, Inc. | 2012 | Class I |
| +2 | K141977 | Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo… | Siemens Medical Solutions USA, Inc. | 2014 | — |
| +3 | K151579 | MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM… | Siemens Medical Solutions USA, Inc. | 2015 | Class I |
| +3 | K153343 | MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit | Siemens Medi Cal Solutions, Inc. | 2016 | Class I |
| +2 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 1 |
| 2013 | 12 | 2 |
| 2014 | 7 | 0 |
| 2015 | 7 | 1 |
| 2016 | 5 | 1 |
| 2017 | 15 | 1 |
| 2018 | 18 | 2 |
| 2019 | 19 | 1 |
| 2020 | 22 | 3 |
| 2021 | 9 | 1 |
| 2022 | 22 | 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? (6)
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 |
|---|---|---|---|
| * | K101347 | Magnetom Aera; Magnetom SkyraSummary page 2…e following predicate devices: Predicate Device Name 510(k) Number FDAeanc Siemens MAGNETOM Aera (1.5T) and MAGNETOM Skyra with K1 01 347 October 1, 2010 syngo® MR D1i1A Siemens MAGNETOM Skyra (3T) K101347 October 1,2010 with syngo®… | 2010 |
| * | K082427 | Syngo MR B17Summary page 2…October 1, 2010 syngo® MR D1i1A Siemens MAGNETOM Skyra (3T) K101347 October 1,2010 with syngo® MR Dl11A syngo® MR 817 Software update K082427 November 7, 2008 Siemens MAGNETOM Verio (3T) K072237 October 10, 2007 Siemens MAGNETOM Espre… | 2008 |
| * | K072237 | Magnetom VerioSummary page 2…1347 October 1,2010 with syngo® MR Dl11A syngo® MR 817 Software update K082427 November 7, 2008 Siemens MAGNETOM Verio (3T) K072237 October 10, 2007 Siemens MAGNETOM Espree K041112 July 21, 2004 (1.5T) Specialty coils f… | 2007 |
| * | K041112 | Magnetom Espree SystemSummary page 2…e update K082427 November 7, 2008 Siemens MAGNETOM Verio (3T) K072237 October 10, 2007 Siemens MAGNETOM Espree K041112 July 21, 2004 (1.5T) Specialty coils for MAGNETOM Ki103275 January 11, 2011 Aae and MAGNETOM S… | 2004 |
| * | K103275 | Specialty Coils for Magnetom Aera 1.5T & Magnetim Skyra 3T MR SystemsSummary page 2…K072237 October 10, 2007 Siemens MAGNETOM Espree K041112 July 21, 2004 (1.5T) Specialty coils for MAGNETOM Ki103275 January 11, 2011 Aae and MAGNETOM Skyra ______ Sentinelle Vanguard Breast Coils K1 00113… | 2011 |
| * | K100113 | Vanguard Breast Mri Auxiliary Table with 16 Channel Coil Array for GE 3T Mri System…Summary page 2…Specialty coils for MAGNETOM Ki103275 January 11, 2011 Aae and MAGNETOM Skyra ______ Sentinelle Vanguard Breast Coils K1 00113 April 22, 2D1 0 Safety and Effectiveness The device labeling contains instructions for use and any necessary cautions… | 2010 |
What descends from it? (220)
See all 2202 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (21 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 9, 2019 | Class II | Z-2342-2019 | Device Design | Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly. |
| Jul 9, 2019 | Class II | Z-2343-2019 | Device Design | Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly. |
| Apr 24, 2014 | Class II | Z-1663-2014 | Labeling design | Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may have resulted in some users not receiving Operator Manuals. |
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 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · Cites it directly · ◆ 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 · 2 generations on · ◆ in the 2018 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
- 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 · 3 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 · 3 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 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2017 · 4 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 · 4 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 · 5 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
Nearest 12 of 21 shown.
Nearest 5 of 21; all are on the web page.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 11 of the 22 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K121434 (Siemens Medi Cal Solutions, Inc., 2012) has gone furthest, with 215 descendants of its own.
- 3 other devices also cite its predicate K101347.
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. 2011, 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/K111242 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111242: Magnetom Aera and Magnetom Skyra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111242
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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