510(k) · Cleared
Recalled · 2007Magnetom Project 024 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 Jun 5, 1997 after a 90-day review. The FDA summary names its predicate without a number. 1 of the 248 devices in its family, counting itself, has a Class I recall. 247 later devices descend from it. It has been recalled 8 times.
- Decided
- Jun 5, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 8
- Predicates
- 0
247 later devices descend from it, 5 citing it directly. 1 of the 248 devices in this family, counting this one, has a Class I recall.
- This deviceK970852 Magnetom Project 024 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997
- Descendant · cites it directly · 199 of its ownK052423 Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc. · 2006
- Descendant · 2 generations on · 180 of its ownK061964 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2006
- Descendant · 3 generations on · 178 of its ownK072728 Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2008
- Descendant · 3 generations on · 177 of its ownK081734 Syngo Imaging (Version V31)Siemens AG Medical Solutions · 2008 · Recalled
- Descendant · 4 generations on · 176 of its ownK092519 Syngo.XSiemens AG Medical Solutions · 2009 · Recalled
Showing 5 of 247 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…9 generations on · 2025
Most influential descendants
Showing 5 of 247 · See all- K052423Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc. · 2006 · cites it directly199descendants
- K061964Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2006 · 2 generations on180descendants
- K072728Syngo Multimodality WorkplaceSiemens AG Medical Solutions · 2008 · 3 generations on178descendants
- K081734Syngo Imaging (Version V31)Siemens AG Medical Solutions · 2008 · 3 generations on177descendants
- K092519Syngo.XSiemens AG Medical Solutions · 2009 · 4 generations on176descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970852 | Magnetom Project 024 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | — |
| +1 | K052423 | Magnetom Systems with Syngo Expert - I Option | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| +2 | K061964 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2006 | — |
| +3 | K072728 | Syngo Multimodality Workplace | Siemens AG Medical Solutions | 2008 | — |
| +3 | K081734 | Syngo Imaging (Version V31) | Siemens AG Medical Solutions | 2008 | 5 |
| +4 | K092519 | Syngo.X | Siemens AG Medical Solutions | 2009 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 2 | 0 |
| 2010 | 6 | 0 |
| 2011 | 10 | 0 |
| 2012 | 13 | 0 |
| 2013 | 9 | 0 |
| 2014 | 6 | 0 |
| 2015 | 13 | 0 |
| 2016 | 10 | 0 |
| 2017 | 6 | 0 |
| 2018 | 13 | 0 |
| 2019 | 15 | 0 |
| 2020 | 24 | 0 |
| 2021 | 9 | 0 |
| 2022 | 17 | 0 |
| 2023 | 20 | 0 |
| 2024 | 21 | 0 |
| 2025 | 18 | 1 |
| 2026 | 18 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | — | MAGNETOM Vision Named without a submission number | |
| * | — | MAGNETOM Impact Named without a submission number |
What descends from it? (247)
See all 2475 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 1, 2007 | Not classified | Z-1045-2008 | Device Design | Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room. |
| Dec 1, 2007 | Not classified | Z-1042-2008 | Device Design | Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room. |
| Dec 1, 2007 | Not classified | Z-1043-2008 | Device Design | Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room. |
| Dec 1, 2007 | Not classified | Z-1047-2008 | Device Design | Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room. |
| Dec 1, 2007 | Not classified | Z-1048-2008 | Device Design | Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room. |
| Dec 1, 2007 | Not classified | Z-1044-2008 | Device Design | Magnet Quench, unintended- magnet of a mobile MRI system quenched into the exam room. |
| Jul 28, 2004 | Not classified | Z-1396-04 | 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-1397-04 | Other | An input error can be made with Magnetom MRI software. Software allows users to manually change Transmit Reference Voltage in certain windows |
The 5 latest of 8 recalls; the web page lists all.
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.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K052423 (Siemens Medi Cal Solutions, Inc., 2006) has gone furthest, with 199 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 STEMENS MAGNETOM Project 024 is a 1Tesla whole body magnetic resonance imaging (MRI) system intended for general diagnostic 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 exhlbxtmg 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/K970852 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970852: Magnetom Project 024 System (Numaris 3.5 Software).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970852
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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