510(k) · Cleared
ClearedSyngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco Engine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Systems USA · LLZ System, Image Processing, Radiological
Cleared on Jan 6, 2012 as substantially equivalent to K082427 (Siemens Medical Solutions USA, Inc., 2008) and 3 other predicates after a 190-day review. Its family tree reaches back 10 generations to 1991. 1 of the 171 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 6, 2012
- Review
- 190 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K913770 (1991). 170 ancestors in all, the oldest K841997 (1984). No later device cites it as a predicate yet. 1 of the 171 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations between
- 3 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 1 generation backK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
- This deviceK111861 Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA · 2012
Show all 10 generations
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 8 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 7 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 6 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 5 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 4 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 3 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 2 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 1 generation backK093621 Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc. · 2010
- This deviceK111861 Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA · 2012
Class I recalls in this family
- K072237 Magnetom Verio2 generations back · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −9 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −8 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −7 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −6 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −5 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −4 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −3 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −2 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −1 | K093621 | Syngo.Pet&CT Oncology | Siemens Medical Solutions USA, Inc. | 2010 | — |
| 0 (this device) | K111861 | Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco Engine | Siemens Medical Systems USA | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 4 | 0 |
| 1990 | 3 | 0 |
| 1991 | 5 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 5 | 0 |
| 1995 | 4 | 0 |
| 1996 | 9 | 0 |
| 1997 | 7 | 0 |
| 1998 | 14 | 0 |
| 1999 | 6 | 0 |
| 2000 | 11 | 0 |
| 2001 | 15 | 0 |
| 2002 | 13 | 0 |
| 2003 | 6 | 0 |
| 2004 | 13 | 0 |
| 2005 | 10 | 0 |
| 2006 | 10 | 0 |
| 2007 | 7 | 1 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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.
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 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 |
|---|---|---|---|
| * | K082427 | Syngo MR B17Summary page 3…edicate 510(K) Clearance 510(k) Clearance Date Software Name Number Software K082427 November 7, 2008 syngo MR B17 Software K092519… | 2008 |
| * | K092519 | Syngo.XSummary page 3…ber Software K082427 November 7, 2008 syngo MR B17 Software K092519 August 27, 2009 syngo.x (syngovia) __________ Software… | 2009 |
| * | K093621 | Syngo.Pet&CT OncologySummary page 3…K092519 August 27, 2009 syngo.x (syngovia) __________ Software K093621 February 23, 2010 syngo PET&CT Oncolg I_________ Syngo Dosimetrist Workspace… | 2010 |
| * | K101119 | Syngo Dosimetrist Workspace V2.7 Model: 1056864Summary page 3…K093621 February 23, 2010 syngo PET&CT Oncolg I_________ Syngo Dosimetrist Workspace K1 01119 June 6, 2010 v2 .7 __ _ __I__ _ I__ In summary, modifi… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 2 generations back · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 43 of the 170 ancestors have a recall of any class; 1 has a Class I recall.
- 8 other devices also cite its predicate K082427.
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 Oncology is a syngovia-based image viewing, processing and reading software. This software allows for oncological MR image evaluation in a structured way. It is a reading application primarily for convenient reading of MR scans of single or multiple body regions up to the entire body which have been acquired for clinical purposes such as oncological screening, staging and grading. The reading application does not block the display of data from…
Read the full statement (175 words)
syngo.MR Oncology is a syngovia-based image viewing, processing and reading software. This software allows for oncological MR image evaluation in a structured way. It is a reading application primarily for convenient reading of MR scans of single or multiple body regions up to the entire body which have been acquired for clinical purposes such as oncological screening, staging and grading. The reading application does not block the display of data from other modalities that syngovia supports.
syngo.MR Oncology provides analytical tools to help the user assess and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations.
syngo.MR Oncology is designed to support the oncological workflow including interpretation and evaluation of examinations, and follow-up documentation of findings.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo.MR Oncology is a tool to support the standard practices and visual comparisons.
The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111861: Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco Engine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111861
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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