510(k) · Cleared
Recalled · Class I · 2025Magnetom Spectra
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 Jul 16, 2012 as substantially equivalent to K101347 (Siemens Medical Solutions USA, Inc., 2010) and 2 other predicates after a 91-day review. Its family tree reaches back 8 generations to 1997. 3 of the 14 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 3 times, including a Class I recall.
- Decided
- Jul 16, 2012
- Review
- 91 days
- Class
- Class II
- Product code
- LNH
- Recalls
- 3 (1 Class I)
- Predicates
- 3
Its longest line of descent runs back 8 generations to K971684 (1997). 12 ancestors in all. 1 later device descends from it, 1 citing it directly. 3 of the 14 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 7 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 6 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 5 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 4 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 3 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 2 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 1 generation backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- This deviceK121160 Magnetom SpectraSiemens Medical Solutions USA, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK153447 MAGNETOM SpectraSiemens Medical Solutions USA, Inc. · 2016 · Recalled
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K153447MAGNETOM SpectraSiemens Medical Solutions USA, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −7 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −6 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −5 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −4 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −3 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −2 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −1 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
| 0 (this device) | K121160 | Magnetom Spectra | Siemens Medical Solutions USA, Inc. | 2012 | — |
| +1 | K153447 | MAGNETOM Spectra | Siemens Medical Solutions USA, Inc. | 2016 | 1 |
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 |
|---|---|---|
| 2016 | 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.
3 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 |
|---|---|---|---|
| * | K101347 | Magnetom Aera; Magnetom SkyraSummary page 2…ice Name Clearance FDlae Number Dt Siemens MAGNETOM Skyra (3T) K101 347 October 1, 2010 Siemens MAGNETOM Verio (3T) K072237 October 10, 2007 syngo® MR 617 Software upd… | 2010 |
| * | K072237 | Magnetom VerioSummary page 2…Number Dt Siemens MAGNETOM Skyra (3T) K101 347 October 1, 2010 Siemens MAGNETOM Verio (3T) K072237 October 10, 2007 syngo® MR 617 Software update K082427 November 7, 2008 Hardware and Softw… | 2007 |
| * | K082427 | Syngo MR B17Summary page 2…K101 347 October 1, 2010 Siemens MAGNETOM Verio (3T) K072237 October 10, 2007 syngo® MR 617 Software update K082427 November 7, 2008 Hardware and Software Updates to MAGNETOM Aera (1.5T) and Skyra (3T) Kl 4… | 2008 |
| * | — | Hardware and Software Updates to MAGNETOM Aera (1.5T) and Skyra (3T) Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153447 | MAGNETOM Spectra | 2016 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 28, 2025 | Class I | Z-2663-2025 | Under Investigation by firm | There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within… |
| Jul 9, 2019 | Class II | Z-2344-2019 | Device Design | Potential of an open port in the quench venting system when using the optional horizontal outlet on the quench line assembly. |
| Sep 12, 2012 | Class II | Z-2464-2012 | Device Design | When positioning the Flex Large 4 Coil (part No. 8625761) off-center in left-right direction as it is used for example for hip and shoulder imaging and, in addition at an off-center position with respect to the head-foot direction, the… |
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.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 8 of the 12 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K153447 (Siemens Medical Solutions USA, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K101347.
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. 2012, this device’s year, is highlighted.
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 Spectra 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. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These…
Read the full statement (119 words)
The MAGNETOM Spectra 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.
Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Spectra may also be used for imaging during interventional procedures when performed with MR compatible devices such as inroom display and MR-safe biopsy needles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121160: Magnetom Spectra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121160
Report an extraction error
Are you the manufacturer?
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