510(k) · Cleared
ClearedMagnetom Systems with Software Syngo MR 2006A
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 4, 2005 as substantially equivalent to K032428 (Siemens Medical Solutions USA, Inc., 2003) and 3 other predicates after a 56-day review. Its family tree reaches back 3 generations to 1997. 22 of the 320 devices in its family, counting itself, have a Class I recall. 312 later devices descend from it.
- Decided
- Oct 4, 2005
- Review
- 56 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K971684 (1997). 7 ancestors in all. 312 later devices descend from it, 2 citing it directly. 22 of the 320 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 2 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 1 generation backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- This deviceK052164 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
- Descendant · 2 generations on · 300 of its ownK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- Descendant · 2 generations on · 229 of its ownK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- Descendant · 2 generations on · 228 of its ownK071925 Magnetom EssenzaSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 224 of its ownK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
Showing 5 of 312 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 312 · See all- K062454Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006 · cites it directly308descendants
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 2 generations on300descendants
- K082427Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008 · 2 generations on229descendants
- K071925Magnetom EssenzaSiemens Medical Solutions USA, Inc. · 2007 · 2 generations on228descendants
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 3 generations on224descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −2 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −1 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| 0 (this device) | 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 | — |
| +2 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| +2 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| +2 | K071925 | Magnetom Essenza | Siemens Medical Solutions USA, Inc. | 2007 | 1 |
| +3 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 1 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 1 |
| 2011 | 7 | 0 |
| 2012 | 9 | 2 |
| 2013 | 18 | 2 |
| 2014 | 9 | 0 |
| 2015 | 12 | 1 |
| 2016 | 9 | 1 |
| 2017 | 20 | 1 |
| 2018 | 21 | 2 |
| 2019 | 25 | 1 |
| 2020 | 28 | 3 |
| 2021 | 12 | 1 |
| 2022 | 29 | 2 |
| 2023 | 32 | 3 |
| 2024 | 21 | 0 |
| 2025 | 24 | 1 |
| 2026 | 23 | 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? (4)
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 |
|---|---|---|---|
| * | K032428 | Magnetom Avanto MR SystemSummary page 2…will be available for the following MAGNETOM Family systems: * The MAGNETOM 1.5 Telsa Avanto system with syngo MR2004V was described in premarket notification K032428 which received FDA clearance October 16, 2003. * The MAGNETOM 1.5 Telsa Espree system with syngo MR2005E was described in… | 2003 |
| * | K041112 | Magnetom Espree SystemSummary page 2…cation K032428 which received FDA clearance October 16, 2003. * The MAGNETOM 1.5 Telsa Espree system with syngo MR2005E was described in premarket notification K041112 which received FDA clearance July 21, 2004. * The MAGNETOM 1.5 Telsa Symphony a Tim System with syngo MR2006T was descr… | 2004 |
| * | K050199 | Magnetom Symphony a Tim SystemSummary page 2…n K041112 which received FDA clearance July 21, 2004. * The MAGNETOM 1.5 Telsa Symphony a Tim System with syngo MR2006T was described in premarket notification K050199 which received FDA clearance February 18, 2005. * The MAGNETOM 3 Telsa Trio a Tim System with syngo 2006T was described… | 2005 |
| * | K050200 | Magnetom Trio a Tim SystemSummary page 2…K050199 which received FDA clearance February 18, 2005. * The MAGNETOM 3 Telsa Trio a Tim System with syngo 2006T was described in premarket notification K050200 which received FDA clearance February 28, 2005. Siemens Medical Solutions, Inc., intends to offer a software and hardware upgra… | 2005 |
What descends from it? (312)
See all 3122 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (22 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.
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- 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?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 1.2 years on median.
- 6 of the 7 ancestors have a recall of any class.
- Of its descendants, K062454 (Siemens Medi Cal Solutions, Inc., 2006) has gone furthest, with 308 descendants of its own.
- 10 other devices also cite its predicate K032428.
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 Espree" the "MAGNETOM Avanto" the "MAGNETOM Symphony a Tim System" the "MAGNETOM Trio a Tim System" 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. These images and/or spectra, when interpreted by a trained…
Read the full statement (116 words)
The "MAGNETOM Espree"
the "MAGNETOM Avanto"
the "MAGNETOM Symphony a Tim System"
the "MAGNETOM Trio a Tim System"
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. These images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.
The "MAGNETOM Espree"
the "MAGNETOM Avanto"
the "MAGNETOM Symphony a Tim System"
the "MAGNETOM Trio a Tim System"
may also be used for imaging during interventional procedures 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/K052164 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052164: Magnetom Systems with Software Syngo MR 2006A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052164
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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