510(k) · Cleared
Recalled · Class I · 2025MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit
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 Apr 15, 2016 as substantially equivalent to K151579 (Siemens Medical Solutions USA, Inc., 2015) and 1 other predicate after a 148-day review. Its family tree reaches back 12 generations to 1997. 18 of the 119 devices in its family, counting itself, have a Class I recall. 84 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Apr 15, 2016
- Review
- 148 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 12 generations to K971684 (1997). 34 ancestors in all, the oldest K932271 (1994). 84 later devices descend from it, 8 citing it directly. 18 of the 119 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 8 generations between
- 3 generations backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- 2 generations backK141977 Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with…Siemens Medical Solutions USA, Inc. · 2014
- 1 generation backK151579 MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit…Siemens Medical Solutions USA, Inc. · 2015 · Recalled (Class I)
- This deviceK153343 MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016
- Descendant · cites it directly · 30 of its ownK170396 MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2017 · Recalled (Class I)
- Descendant · 2 generations on · 28 of its ownK181433 MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2018
- Descendant · 3 generations on · 26 of its ownK183254 Magnetom VidaSiemens Medical Solutions USA, Inc. · 2019
- Descendant · cites it directly · 23 of its ownK163294 syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc. · 2017
- Descendant · 4 generations on · 22 of its ownK192924 MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida FitSiemens Medical Solutions USA, Inc. · 2020 · Recalled (Class I)
Show all 12 generations
- Root · 12 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 11 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 10 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 9 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 8 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 7 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 6 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 5 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- 4 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 3 generations backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- 2 generations backK141977 Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with…Siemens Medical Solutions USA, Inc. · 2014
- 1 generation backK151579 MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit…Siemens Medical Solutions USA, Inc. · 2015 · Recalled (Class I)
- This deviceK153343 MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016
Showing 5 of 84 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 84 · See all- K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2017 · cites it directly30descendants
- K181433MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2018 · 2 generations on28descendants
- K183254Magnetom VidaSiemens Medical Solutions USA, Inc. · 2019 · 3 generations on26descendants
- K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc. · 2017 · cites it directly23descendants
- K192924MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida FitSiemens Medical Solutions USA, Inc. · 2020 · 4 generations on22descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −11 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −10 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −9 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −8 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −7 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −6 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −5 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
| −4 | K111242 | Magnetom Aera and Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| −3 | 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 | — |
| −1 | K151579 | MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM… | Siemens Medical Solutions USA, Inc. | 2015 | Class I |
| 0 (this device) | K153343 | MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit | Siemens Medi Cal Solutions, Inc. | 2016 | — |
| +1 | K170396 | MAGNETOM Vida | Siemens Medical Solutions USA, Inc. | 2017 | Class I |
| +2 | K181433 | MAGNETOM Vida | Siemens Medical Solutions USA, Inc. | 2018 | — |
| +3 | K183254 | Magnetom Vida | Siemens Medical Solutions USA, Inc. | 2019 | — |
| +1 | K163294 | syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology | Siemens Medical Solutions USA, Inc. | 2017 | — |
| +4 | K192924 | MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit | Siemens Medical Solutions USA, Inc. | 2020 | Class I |
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 |
|---|---|---|
| 2017 | 5 | 1 |
| 2018 | 8 | 1 |
| 2019 | 8 | 1 |
| 2020 | 10 | 3 |
| 2021 | 4 | 1 |
| 2022 | 11 | 2 |
| 2023 | 11 | 3 |
| 2024 | 8 | 0 |
| 2025 | 8 | 1 |
| 2026 | 11 | 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.
18 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? (2)
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 |
|---|---|---|---|
| * | K151579 | MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma… Our reading of the summary gave K151597, FDA’s number for Family of Steam Sterilizers B 28 series (Cefla S.C.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “syngo MR E11B for MAGNETOM Aera (24) (1.5T), MAGNETOM Avantofit…”. | 2015 |
| * | K141977 | Magnetom Aera with Software Syngo MR E11A, Magnetom Skyra with Software Syngo MR E11A…Summary page 7…and MAGNETOM Prismafit systems (“syngo MR E11C”) has the same technological characteristics as the predicate devices MR systems (K151579; cleared September 29, 2015 and K141977, cleared November 19, 2014). The subject device is substantially equivalent to the predicate devices with regard to the operation… | 2014 |
What descends from it? (84)
See all 848 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170396 | MAGNETOM Vida Class I | 2017 | 30 |
| K163294 | syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology | 2017 | 23 |
| K163234 | Biograph mMR with syngo MR E11P system software | 2017 | 12 |
| K181322 | MAGNETOM Sola | 2018 | 8 |
| K163312 | MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software | 2017 | 4 |
| K173592 | MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit Class I | 2018 | 3 |
| K182129 | MAGNETOM Sola | 2018 | 1 |
| K191050 | MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease… | 2019 | 0 |
Has anything in its family been recalled? (18 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 28, 2025 | Class I | Z-2659-2025 | 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… |
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.
- K151579MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medical Solutions USA, Inc. · 2015 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 4 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2017 · Cites it directly · ◆ 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 · Cites it directly · ◆ in the 2018 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
- K183244MAGNETOM LuminaSiemens Medical Solutions USA, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K192924MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida FitSiemens Medical Solutions USA, Inc. · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 12 Class I recalls
- K220939MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50ASiemens Medical Solutions USA, Inc. · 2022 · 5 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
- K203443MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM AlteaSiemens Medical Solutions USA, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K202014Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fitSiemens Medical Solutions USA, Inc. · 2020 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
Nearest 12 of 17 shown.
Nearest 5 of 17; all are on the web page.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 15 of the 34 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K170396 (Siemens Medical Solutions USA, Inc., 2017) has gone furthest, with 30 descendants of its own.
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. 2016, 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 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…
Read the full statement (120 words)
The MAGNETOM systems 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/K153343 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153343: MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153343
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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