510(k) · Cleared
Recalled · Class II · 2015Magnetom Avanto MR System
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 Oct 16, 2003 as substantially equivalent to K993731 (Siemens Medical Solutions USA, Inc., 1999) and 1 other predicate after a 79-day review. Its family tree reaches back 1 generation to 1997. 22 of the 434 devices in its family, counting itself, have a Class I recall. 431 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 16, 2003
- Review
- 79 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 1 generation to K971684 (1997). 2 ancestors in all. 431 later devices descend from it, 11 citing it directly. 22 of the 434 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- This deviceK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003
- Descendant · cites it directly · 428 of its ownK050200 Magnetom Trio a Tim SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- Descendant · cites it directly · 422 of its ownK050199 Magnetom Symphony a Tim SystemSiemens Medical Solution · 2005
- Descendant · cites it directly · 422 of its ownK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- Descendant · cites it directly · 312 of its ownK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- Descendant · cites it directly · 308 of its ownK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
Showing 5 of 431 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 431 · See all- K050200Magnetom Trio a Tim SystemSiemens Medical Solutions USA, Inc. · 2005 · cites it directly428descendants
- K050199Magnetom Symphony a Tim SystemSiemens Medical Solution · 2005 · cites it directly422descendants
- K041112Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · cites it directly422descendants
- K052164Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005 · cites it directly312descendants
- K062454Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006 · cites it directly308descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| 0 (this device) | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| +1 | K050200 | Magnetom Trio a Tim System | Siemens Medical Solutions USA, Inc. | 2005 | 3 |
| +1 | K050199 | Magnetom Symphony a Tim System | Siemens Medical Solution | 2005 | — |
| +1 | 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 | — |
| +1 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 1 |
| 2008 | 7 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 1 |
| 2011 | 13 | 0 |
| 2012 | 13 | 2 |
| 2013 | 23 | 2 |
| 2014 | 16 | 0 |
| 2015 | 18 | 1 |
| 2016 | 15 | 1 |
| 2017 | 23 | 1 |
| 2018 | 26 | 2 |
| 2019 | 29 | 1 |
| 2020 | 39 | 3 |
| 2021 | 18 | 1 |
| 2022 | 37 | 2 |
| 2023 | 41 | 3 |
| 2024 | 31 | 0 |
| 2025 | 32 | 1 |
| 2026 | 27 | 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? (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 |
|---|---|---|---|
| * | K993731 | Sonata Gradients/Magnetom Symphony SystemSummary page 2…FDA FDA Clearance Date Number I Siemens MAGNETOM 1.5 T Sonata I K99373 1 I 12/23/99 I Siemens MAGNETOM 1.5 T Symphony I K97 1684 I 08/05/97 General Safety… | 1999 |
| * | K971684 | Magnetom Project 047 System (Numaris 3.5 Software)Summary page 2…Number I Siemens MAGNETOM 1.5 T Sonata I K99373 1 I 12/23/99 I Siemens MAGNETOM 1.5 T Symphony I K97 1684 I 08/05/97 General Safety and Effectiveness Concerns: Operation of the MAGNETOM Avanto System is substantially equi… | 1997 |
What descends from it? (431)
See all 43111 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050200 | Magnetom Trio a Tim System | 2005 | 428 |
| K050199 | Magnetom Symphony a Tim System | 2005 | 422 |
| K041112 | Magnetom Espree System | 2004 | 422 |
| K052164 | Magnetom Systems with Software Syngo MR 2006A | 2005 | 312 |
| K062454 | Magnetom Systems - I-Class and T-Class Releases | 2006 | 308 |
| K071925 | Magnetom Essenza | 2007 | 228 |
| K083166 | Specialty Coils for the Magnetom Essenza | 2009 | 222 |
| K052423 | Magnetom Systems with Syngo Expert - I Option | 2006 | 199 |
| K063373 | Flex Loop Coil Set 3T | 2006 | 4 |
| K190524 | MRopen 0.5 T | 2019 | 2 |
Has anything in its family been recalled? (22 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 7, 2015 | Class II | Z-0467-2016 | Other | Possible installation error of the quench lines of superconducting magnets, used to vent helium gas in the rare event of a quench. Any restriction, obstruction, or improper installation of the quench line may cause the helium gas to be… |
| Mar 3, 2011 | Not classified | Z-2021-2011 | Other | Firm discovered during product monitoring that on a few systems the gradient cable connections did not meet their specifications after installation. The potential exists for a cable connection to become overheated, leading to the emission… |
| Aug 12, 2005 | Not classified | Z-1528-05 | Other | there is a misalignment of the patient table that may occur between the patient table and the opening to the magnet bore |
| Jul 28, 2004 | Not classified | Z-1395-04 | Other | An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows |
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 on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K130885Magnetom Avanto-Fit, Magnetom Skyra-FitSiemens Medical Solutions USA, Inc. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K121160Magnetom SpectraSiemens Medical Solutions USA, Inc. · 2012 · 3 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 · 3 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 · 4 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
- K132119Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc. · 2013 · 4 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 · 5 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 · 5 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 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2017 · 6 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 · 6 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?
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 Avanto is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images andor spectra, and that display the internal structure and/or function of the head, body, or extremities. These images andor spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Avanto 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/K032428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032428: Magnetom Avanto MR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032428
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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