510(k) · Cleared
Clearedsyngo.MR General, syngo.MR Cardiology, syngo.MR Neurology
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 Feb 6, 2017 as substantially equivalent to K130749 (Siemens Medical Solutions USA, Inc., 2013) and 3 other predicates after a 76-day review. Its family tree reaches back 13 generations to 1997. 5 of the 212 devices in its family, counting itself, have a Class I recall. 23 later devices descend from it.
- Decided
- Feb 6, 2017
- Review
- 76 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K971684 (1997). 188 ancestors in all, the oldest K837107 (1983). 23 later devices descend from it, 2 citing it directly. 5 of the 212 devices in this family, counting this one, have a Class I recall.
- Root · 13 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 9 generations between
- 3 generations backK130749 Syngo.MR General; Syngo.MR Cardiology; Syngo.MR VascularSiemens Medical Solutions USA, Inc. · 2013
- 2 generations backK133401 Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR…Siemens Medical Solutions USA, Inc. · 2014
- 1 generation backK151353 syngo.MR Neurology, syngo.MR OncologySiemens Medical Solutions USA, Inc. · 2015
- This deviceK163294 syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc. · 2017
- 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
Show all 13 generations
- Root · 13 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 12 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 11 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 10 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
- 9 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
- 8 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
- 7 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
- 6 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
- 5 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
- 4 generations backK121434 Software Syngo MR D13A for the Magnetom Systems…Siemens Medi Cal Solutions, Inc. · 2012 · Recalled (Class I)
- 3 generations backK130749 Syngo.MR General; Syngo.MR Cardiology; Syngo.MR VascularSiemens Medical Solutions USA, Inc. · 2013
- 2 generations backK133401 Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR…Siemens Medical Solutions USA, Inc. · 2014
- 1 generation backK151353 syngo.MR Neurology, syngo.MR OncologySiemens Medical Solutions USA, Inc. · 2015
- This deviceK163294 syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc. · 2017
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K153343 MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma…direct predicate · 2016
- K151579 MAGNETOM Aera (24-channel), MAGNETOM Avanto fit…2 generations back · 2015
- K121434 Software Syngo MR D13A for the Magnetom Systems…2 generations back · 2012
- K101347 Magnetom Aera; Magnetom Skyra4 generations back · 2010
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 |
|---|---|---|---|---|---|
| −13 | K971684 | Magnetom Project 047 System (Numaris 3.5 Software) | Siemens Medical Solutions USA, Inc. | 1997 | 4 |
| −12 | K032428 | Magnetom Avanto MR System | Siemens Medical Solutions USA, Inc. | 2003 | 4 |
| −11 | K041112 | Magnetom Espree System | Siemens Medical Solutions USA, Inc. | 2004 | 4 |
| −10 | K052164 | Magnetom Systems with Software Syngo MR 2006A | Siemens Medical Solutions USA, Inc. | 2005 | — |
| −9 | K062454 | Magnetom Systems - I-Class and T-Class Releases | Siemens Medi Cal Solutions, Inc. | 2006 | — |
| −8 | K072237 | Magnetom Verio | Siemens Medical Solutions USA, Inc. | 2007 | Class I |
| −7 | K082427 | Syngo MR B17 | Siemens Medical Solutions USA, Inc. | 2008 | — |
| −6 | K101347 | Magnetom Aera; Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2010 | Class I |
| −5 | K111242 | Magnetom Aera and Magnetom Skyra | Siemens Medical Solutions USA, Inc. | 2011 | 3 |
| −4 | K121434 | Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/Verio | Siemens Medi Cal Solutions, Inc. | 2012 | Class I |
| −3 | K130749 | Syngo.MR General; Syngo.MR Cardiology; Syngo.MR Vascular | Siemens Medical Solutions USA, Inc. | 2013 | — |
| −2 | K133401 | Syno MR Neurology, Syngo MR Oncology, Syngo. MR Brevis, Syngo MMR General | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −1 | K151353 | syngo.MR Neurology, syngo.MR Oncology | Siemens Medical Solutions USA, Inc. | 2015 | — |
| 0 (this device) | K163294 | syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology | Siemens Medical Solutions USA, Inc. | 2017 | — |
| +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 |
|---|---|---|
| 1983 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 6 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 9 | 0 |
| 1997 | 8 | 0 |
| 1998 | 12 | 0 |
| 1999 | 6 | 0 |
| 2000 | 11 | 0 |
| 2001 | 18 | 0 |
| 2002 | 14 | 0 |
| 2003 | 8 | 0 |
| 2004 | 15 | 0 |
| 2005 | 10 | 0 |
| 2006 | 10 | 0 |
| 2007 | 8 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 1 |
| 2016 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 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.
5 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? (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 |
|---|---|---|---|
| * | K130749 | Syngo.MR General; Syngo.MR Cardiology; Syngo.MR VascularSummary page 9…for Medical Primary Predicate Device FDA Clearance Code Device syngo.x syngo.MR Post-Processing K130749 MR General Software cleared August 20, LLZ, LNH MR Cardiology (Version SMRVA16A)… | 2013 |
| * | K151353 | syngo.MR Neurology, syngo.MR OncologySummary page 8…eters (FA, RD, AD, ADC, …) using ROI, VOI, or voxels. · Neuro-specific Mean Curve Tool (minor improvement): The application syngo.MR Neuro Dynamics described in K151353 (and cleared August 07, 2015) is only available within syngo.MR Neuro Perfusion (neuro- specific Mean Curve Tool), bu… | 2015 |
| * | K153343 | MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSummary page 10…ance Device Code Device syngo.x syngo MR E11C Software for Siemens MR Systems: K153343 MR General MAGNETOM Aera (1.5T), LNH, LNI, clear… | 2016 |
| * | K150843 | syngo®.via (version VB10A)Summary page 10…M Skyra (3T) and MOS 2016 MAGNETOM Prisma/Prismafit (3T) K150843 MR General syngo.via (VB10) cleared April 24, LLZ MR Cardiology… | 2015 |
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? (5 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.
- K153343MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fitSiemens Medi Cal Solutions, Inc. · 2016 · Direct predicate · ◆ in the 2016 ancestors 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 · 2 generations back · ◆ in the 2015 ancestors bar of FIG. 12 Class I recalls
- K121434Software Syngo MR D13A for the Magnetom Systems Aera/Skyra/Avanto/VerioSiemens Medi Cal Solutions, Inc. · 2012 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 4 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 45 of the 188 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K180336 (Siemens Medical Solutions USA, Inc., 2018) has gone furthest, with 21 descendants of its own.
- 6 other devices also cite its predicate K130749.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
The software comprising the syngo.MR post-processing applications is post-processing software/applications to be used for viewing and evaluating the designated images provided by a magnetic resonance diagnostic device. All of the software applications comprising the syngo.MR post-processing applications have their own indications for use. syngo.MR General is a syngo based post-processing software for viewing, manipulating and evaluating MR images.…
Read the full statement (90 words)
The software comprising the syngo.MR post-processing applications is post-processing software/applications to be used for viewing and evaluating the designated images provided by a magnetic resonance diagnostic device. All of the software applications comprising the syngo.MR post-processing applications have their own indications for use.
syngo.MR General is a syngo based post-processing software for viewing, manipulating and evaluating MR images.
syngo.MR Cardiology is a syngo based post-processing software for viewing, manipulating and evaluating MR cardiac images.
syngo.MR Neurology is a syngo based post-processing software for viewing, manipulating, and evaluating MR neurological images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163294: syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163294
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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