510(k) · Cleared
ClearedSyngo.MR Spectro Engine, Syngo.MR Spectro SVS, Syngo.MR Spectro Csi, Syngo.MR Spectro Extension
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · LLZ System, Image Processing, Radiological
Cleared on Apr 13, 2012 as substantially equivalent to K101347 (Siemens Medical Solutions USA, Inc., 2010) and 1 other predicate after a 72-day review. Its family tree reaches back 8 generations to 1997. 2 of the 45 devices in its family, counting itself, have a Class I recall. 23 later devices descend from it.
- Decided
- Apr 13, 2012
- Review
- 72 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K971684 (1997). 21 ancestors in all, the oldest K970852 (1997). 23 later devices descend from it, 2 citing it directly. 2 of the 45 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 deviceK120315 Syngo.MR Spectro Engine, Syngo.MR Spectro SVS, Syngo.MR Spectro Csi…Siemens Medical Solutions USA, Inc. · 2012
- Descendant · cites it directly · 21 of its ownK180336 syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2018
- Descendant · 2 generations on · 14 of its ownK182904 syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2019
- Descendant · 3 generations on · 11 of its ownK193290 AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc. · 2020
- Descendant · 4 generations on · 6 of its ownK220497 CoLumboSmart Soft Healthcare AD · 2022
- Descendant · 4 generations on · 3 of its ownK213706 AI-Rad Companion Brain MRSiemens Healthcare GmbH · 2022
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 23 · See all- K180336syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2018 · cites it directly21descendants
- K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc. · 2019 · 2 generations on14descendants
- K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc. · 2020 · 3 generations on11descendants
- K220497CoLumboSmart Soft Healthcare AD · 2022 · 4 generations on6descendants
- K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH · 2022 · 4 generations on3descendants
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) | K120315 | Syngo.MR Spectro Engine, Syngo.MR Spectro SVS, Syngo.MR Spectro Csi, Syngo.MR… | Siemens Medical Solutions USA, Inc. | 2012 | — |
| +1 | K180336 | syngo.MR Applications | Siemens Medical Solutions USA, Inc. | 2018 | — |
| +2 | K182904 | syngo.MR Applications | Siemens Medical Solutions USA, Inc. | 2019 | — |
| +3 | K193290 | AI-Rad Companion Brain MR | Siemens Medical Solutions USA, Inc. | 2020 | — |
| +4 | K220497 | CoLumbo | Smart Soft Healthcare AD | 2022 | — |
| +4 | K213706 | AI-Rad Companion Brain MR | Siemens Healthcare GmbH | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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.
2 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 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 |
|---|---|---|---|
| * | K101347 | Magnetom Aera; Magnetom SkyraSummary page 3…Clearance Dt Number MAGNETOM Aera, MAGNETOM Skyra K101347 October 01, 2010 with software syngo MR Dl11A _________… | 2010 |
| * | K092519 | Syngo.XSummary page 3…October 01, 2010 with software syngo MR Dl11A _________ syngo.X®3 K092519 Augs2,09 7. Summary of Technological Characteristics of the Principal Device as Compared With the Predicate Device… | 2009 |
What descends from it? (23)
See all 232 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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.
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.
- 13 of the 21 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K180336 (Siemens Medical Solutions USA, Inc., 2018) has gone furthest, with 21 descendants of its own.
- 3 other devices also cite its predicate K101347.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
syngo.MR Spectroscopy is a post-processing application to analyze and evaluate MR spectroscopy data. It provides evaluation of MR Single Voxel Spectroscopy (SVS) data and MR Chemical Shift Imaging (CSI) data with workflow guidance to support the diagnostic process. syngo. MR Spectroscopy includes the possibility of an integrated reading of MR images and spectroscopy data for spectroscopy exams and focuses on ease-of-use by reducing complexity. A novel…
Read the full statement (161 words)
syngo.MR Spectroscopy is a post-processing application to analyze and evaluate MR spectroscopy data. It provides evaluation of MR Single Voxel Spectroscopy (SVS) data and MR Chemical Shift Imaging (CSI) data with workflow guidance to support the diagnostic process.
syngo. MR Spectroscopy includes the possibility of an integrated reading of MR images and spectroscopy data for spectroscopy exams and focuses on ease-of-use by reducing complexity. A novel fit-algorithm reduces the need for manual data processing and offers the user reproducible evaluation results. When interpreted by a trained physician, these results provide information that may assist in diagnosis.
The post-processing tool fits and displays spectra and provides intuitive representations of the metabolic profile. The calculation and display of predefined results such as spectra, spectral maps, and metabolite images is provided. The evaluation can be adapted by the customer via protocol modification and task configurations. Interactive reading of spectroscopy exams is supported by side-by-side display of MR images and spectroscopy results, and synchronized display.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120315: Syngo.MR Spectro Engine, Syngo.MR Spectro SVS, Syngo.MR Spectro Csi, Syngo.MR Spectro Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120315
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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