510(k) · Cleared
Recalled · 2007Magnetom Project 047 System (Numaris 3.5 Software)
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 Aug 5, 1997 after a 90-day review. The FDA summary names its predicate without a number. 22 of the 443 devices in its family, counting itself, have a Class I recall. 442 later devices descend from it. It has been recalled 4 times.
- Decided
- Aug 5, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 4
- Predicates
- 0
442 later devices descend from it, 9 citing it directly. 22 of the 443 devices in this family, counting this one, have a Class I recall.
- This deviceK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997
- Descendant · cites it directly · 431 of its ownK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 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 · 2 generations on · 422 of its ownK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 312 of its ownK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
Showing 5 of 442 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 442 · See all- K032428Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · cites it directly431descendants
- K050200Magnetom Trio a Tim SystemSiemens Medical Solutions USA, Inc. · 2005 · 2 generations on428descendants
- K050199Magnetom Symphony a Tim SystemSiemens Medical Solution · 2005 · cites it directly422descendants
- K041112Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · 2 generations on422descendants
- K052164Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005 · 2 generations on312descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | — |
| +1 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| +2 | K050200 | Magnetom Trio a Tim System | Siemens Medical Solutions USA, Inc. | 2005 | 3 |
| +1 | K050199 | Magnetom Symphony a Tim System | Siemens Medical Solution | 2005 | — |
| +2 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| +2 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 1 |
| 2008 | 8 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 1 |
| 2011 | 14 | 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 | 42 | 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 |
|---|---|---|---|
| * | — | SIEMENS MAGNETOM Vision Named without a submission number | |
| * | — | SIEMENS MAGNETOM Impact Named without a submission number |
What descends from it? (442)
See all 4429 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032428 | Magnetom Avanto MR System | 2003 | 431 |
| K050199 | Magnetom Symphony a Tim System | 2005 | 422 |
| K071925 | Magnetom Essenza | 2007 | 228 |
| K052423 | Magnetom Systems with Syngo Expert - I Option | 2006 | 199 |
| K020991 | Syngo MR 2002B | 2002 | 6 |
| K063373 | Flex Loop Coil Set 3T | 2006 | 4 |
| K020268 | Isaac 1.5 T MR System | 2002 | 0 |
| K012202 | Numaris 4VA15A | 2001 | 0 |
| K994315 | CP Peripheral Angio Array Coil/ Magnetom Symphony System | 2000 | 0 |
Has anything in its family been recalled? (22 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 1, 2007 | Not classified | Z-1046-2008 | Device Design | Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room. |
| Dec 1, 2007 | Not classified | Z-1049-2008 | Device Design | Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room. |
| Jul 28, 2004 | Not classified | Z-1399-04 | Other | An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows |
| Jul 28, 2004 | Not classified | Z-1398-04 | 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 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K130885Magnetom Avanto-Fit, Magnetom Skyra-FitSiemens Medical Solutions USA, Inc. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K121160Magnetom SpectraSiemens Medical Solutions USA, Inc. · 2012 · 4 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 · 4 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 · 5 generations on · ◆ in the 2018 descendants bar of FIG. 12 Class I recalls
- K132119Magnetom Prisma, Magnetom Prisma FitSiemens Medical Solutions USA, Inc. · 2013 · 5 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 · 6 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 · 6 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 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K170396MAGNETOM VidaSiemens Medical Solutions USA, Inc. · 2017 · 7 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 · 7 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?
- Of its descendants, K032428 (Siemens Medical Solutions USA, Inc., 2003) has gone furthest, with 431 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.
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 SIEMENS MAGNETOM Project 047 is a 1.5 Tesla whole body magnetic resonance imaging (MRI) system intended-for general diagrostic use: ‘This' MRI system will present images which reflect the spatial distribution and/or magnetic resonance spectra which are a function of the frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971684: Magnetom Project 047 System (Numaris 3.5 Software).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971684
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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