510(k) · Cleared
ClearedMagnetom 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 May 17, 2013 as substantially equivalent to K121434 (Siemens Medi Cal Solutions, Inc., 2012) after a 185-day review. Its family tree reaches back 10 generations to 1997. 4 of the 49 devices in its family, counting itself, have a Class I recall. 16 later devices descend from it.
- Decided
- May 17, 2013
- Review
- 185 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K971684 (1997). 32 ancestors in all, the oldest K932271 (1994). 16 later devices descend from it, 3 citing it directly. 4 of the 49 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 6 generations between
- 3 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- 2 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 1 generation backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- This deviceK123510 Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2013
- Descendant · cites it directly · 12 of its ownK132119 Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc. · 2013 · Recalled (Class I)
- Descendant · cites it directly · 11 of its ownK181370 uMR 780Shanghai United Imaging Healthcare Co., Ltd. · 2018
- Descendant · 2 generations on · 11 of its ownK181371 uMR 790Shanghai United Imaging Healthcare Co., Ltd. · 2018
- Descendant · 2 generations on · 10 of its ownK191157 uMR 780, uMR 790Shanghai United Imaging Healthcare Co., Ltd. · 2019
- Descendant · 3 generations on · 8 of its ownK193200 uMR OmegaShanghai United Imaging Healthcare Co., Ltd. · 2020
Show all 10 generations
- Root · 10 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 9 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 8 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 7 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 6 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 5 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 4 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 3 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- 2 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 1 generation backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- This deviceK123510 Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2013
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 16 · See all- K132119Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc. · 2013 · cites it directly12descendants
- K181370uMR 780Shanghai United Imaging Healthcare Co., Ltd. · 2018 · cites it directly11descendants
- K181371uMR 790Shanghai United Imaging Healthcare Co., Ltd. · 2018 · 2 generations on11descendants
- K191157uMR 780, uMR 790Shanghai United Imaging Healthcare Co., Ltd. · 2019 · 2 generations on10descendants
- K193200uMR OmegaShanghai United Imaging Healthcare Co., Ltd. · 2020 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −9 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −8 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −7 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −6 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −5 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −4 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −3 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
| −2 | K111242 | Magnetom Aera and Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| −1 | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | Siemens Medi Cal Solutions, Inc. | 2012 | Class I |
| 0 (this device) | K123510 | Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2013 | — |
| +1 | K132119 | Magnetom Prisma, Magnetom Prisma Fit | Siemens Medical Solutions USA, Inc. | 2013 | Class I |
| +1 | K181370 | uMR 780 | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | — |
| +2 | K181371 | uMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2018 | — |
| +2 | K191157 | uMR 780, uMR 790 | Shanghai United Imaging Healthcare Co., Ltd. | 2019 | — |
| +3 | K193200 | uMR Omega | Shanghai United Imaging Healthcare Co., Ltd. | 2020 | — |
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 | 1 | 1 |
| 2014 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 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.
4 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? (1)
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 |
|---|---|---|---|
| * | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSummary page 3…icate Device Name Clearance FDA Clearance Date Number MAGNETOM Skyra with syngo MR K121434 November 05, 2012 D13A _ _ _ _ _ _ _ _ _ _ _… | 2012 |
What descends from it? (16)
See all 163 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 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.
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 3 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K132119Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 14 of the 32 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K132119 (Siemens Medical Solutions USA, Inc., 2013) has gone furthest, with 12 descendants of its own.
- 15 other devices also cite its predicate K121434.
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. 2013, 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 Skyra is 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. 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…
Read the full statement (119 words)
The MAGNETOM Skyra is 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.
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 inf6rmation that may assist in
diagnosis.
The MAGNETOM Skyra may also be used for imaging during interventional
procedures when performed with MR compatible devices such as in-room displays and
MR-safe biopsy needles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123510: 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/K123510
Report an extraction error
Are you the manufacturer?
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