510(k) · Cleared
Recalled · 2002OR Table and Headholder/Magnetom Harmony, Symphony, Sonata Systems
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 31, 2001 after an 89-day review. The FDA summary names its predicate without a number. 7 later devices descend from it. It has been recalled once.
- Decided
- Oct 31, 2001
- Review
- 89 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 1
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK012495 OR Table and Headholder/Magnetom Harmony, Symphony, Sonata SystemsSiemens Medical Solutions USA, Inc. · 2001
- Descendant · cites it directly · 6 of its ownK071179 Noras or Head HolderSiemens Medical Solutions USA, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK133506 Noras or Head Holder FlexibilityNoras Mri Products GmbH · 2014
- Descendant · 2 generations on · 1 of its ownK110411 Atama SystemMonteris Medical, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK091439 Head Fixation Arc and Table BaseSurgivision, Inc. · 2009
- Descendant · 3 generations on · 0 of its ownK211658 OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder…Noras Mri Products GmbH · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K071179Noras or Head HolderSiemens Medical Solutions USA, Inc. · 2007 · cites it directly6descendants
- K133506Noras or Head Holder FlexibilityNoras Mri Products GmbH · 2014 · 2 generations on1descendant
- K110411Atama SystemMonteris Medical, Inc. · 2011 · 2 generations on1descendant
- K091439Head Fixation Arc and Table BaseSurgivision, Inc. · 2009 · 2 generations on1descendant
- K211658OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet…Noras Mri Products GmbH · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012495 | OR Table and Headholder/Magnetom Harmony, Symphony, Sonata Systems | Siemens Medical Solutions USA, Inc. | 2001 | — |
| +1 | K071179 | Noras or Head Holder | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +2 | K133506 | Noras or Head Holder Flexibility | Noras Mri Products GmbH | 2014 | — |
| +2 | K110411 | Atama System | Monteris Medical, Inc. | 2011 | — |
| +2 | K091439 | Head Fixation Arc and Table Base | Surgivision, Inc. | 2009 | — |
| +3 | K211658 | OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with… | Noras Mri Products GmbH | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 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.
Planning a device in LNH? 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? (1)
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 |
|---|---|---|---|
| * | — | Neuro II Named without a submission number |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071179 | Noras or Head Holder | 2007 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 27, 2002 | Not classified | Z-0976-03 | Other | OR Table stops during the transfer of the table to the MR system and will not move. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K071179 (Siemens Medical Solutions USA, Inc., 2007) has gone furthest, with 6 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 MAGNETOM Harmony, Symphony, and Sonata System with the OR Table and Headholder is a whole body scanner. The MAGNETOM Systems with the OR Table and Headholder is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by MAGNETOM Systems with the OR Table and Headholder reflect the spatial distribution of protons (hydrogen nuclei)…
Read the full statement (129 words)
The MAGNETOM Harmony, Symphony, and Sonata System with the OR Table and Headholder is a whole body scanner. The MAGNETOM Systems with the OR Table and Headholder is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by MAGNETOM Systems with the OR Table and Headholder reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The OR Table with headholder will be an option for intra-operative and interventional procedures.
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/K012495 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012495: OR Table and Headholder/Magnetom Harmony, Symphony, Sonata Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012495
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026