510(k) · Cleared
ClearedUndecided
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 Jul 30, 2004 as substantially equivalent to K010938 (Siemens Medical Solutions USA, Inc., 2001) and 2 other predicates after a 56-day review. Its family tree reaches back 5 generations to 1991. 1 of the 230 devices in its family, counting itself, has a Class I recall. 222 later devices descend from it.
- Decided
- Jul 30, 2004
- Review
- 56 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K913770 (1991). 7 ancestors in all. 222 later devices descend from it, 1 citing it directly. 1 of the 230 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 4 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 3 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 2 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 1 generation backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- This deviceK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- Descendant · cites it directly · 221 of its ownK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- Descendant · 2 generations on · 201 of its ownK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- Descendant · 3 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 4 generations on · 76 of its ownK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- Descendant · 4 generations on · 70 of its ownK101228 Mirada XDMirada Medical, Ltd. · 2010
Showing 5 of 222 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…8 generations on · 2025
Most influential descendants
Showing 5 of 222 · See all- K053301Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006 · cites it directly221descendants
- K071950Syngo TruedSiemens Medical Solutions USA, Inc. · 2007 · 2 generations on201descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 3 generations on200descendants
- K101749Syngo Trued SoftwareSiemens Medical Solutions · 2010 · 4 generations on76descendants
- K101228Mirada XDMirada Medical, Ltd. · 2010 · 4 generations on70descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −4 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −3 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −2 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −1 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| 0 (this device) | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +1 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| +2 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +3 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +4 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| +4 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 7 | 0 |
| 2016 | 9 | 0 |
| 2017 | 10 | 0 |
| 2018 | 16 | 0 |
| 2019 | 13 | 0 |
| 2020 | 20 | 0 |
| 2021 | 15 | 0 |
| 2022 | 21 | 0 |
| 2023 | 18 | 0 |
| 2024 | 21 | 0 |
| 2025 | 23 | 1 |
| 2026 | 25 | 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? (3)
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 |
|---|---|---|---|
| * | K010938 | Syngo Multimodality WorkstationSummary page 2…FDA Clearance Number syngo Multimodality Workstation K010938 Lung CARE CT Software Package K033374 Advantage Windows CT/PET Fusion… | 2001 |
| * | K033374 | Lungcare CT Software Package with Extended FunctionalitySummary page 2…Number syngo Multimodality Workstation K010938 Lung CARE CT Software Package K033374 Advantage Windows CT/PET Fusion K010336 Leonardo Workstation… | 2003 |
| * | K010336 | Advantage Windows CT/Pet FusionSummary page 2…K010938 Lung CARE CT Software Package K033374 Advantage Windows CT/PET Fusion K010336 Leonardo Workstation K040970 (in review) In summary, Siemens is of the opinion… | 2001 |
What descends from it? (222)
See all 2221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053301 | Cedara I-Response Cedara Pet/CT | 2006 | 221 |
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.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K053301 (Cedara Software Corp., 2006) has gone furthest, with 221 descendants of its own.
- 12 other devices also cite its predicate K010938.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 TrueD is a medical diagnostic application for viewing, image manipulation, 3D visualization and comparison of medical images. syngo TrueD is intended for combining datasets from multiple imaging modalities and/or multiple time-points into a single dataset that accurately represents the information from the initial data. The input datasets could be functional 3D volumes (e.g. PET and SPECT) and/or anatomic 3D volumes (e.g. CT and MR). This “fusion”…
Read the full statement (188 words)
syngo TrueD is a medical diagnostic application for viewing, image manipulation, 3D visualization and comparison of medical images. syngo TrueD is intended for combining datasets from multiple imaging modalities and/or multiple time-points into a single dataset that accurately represents the information from the initial data. The input datasets could be functional 3D volumes (e.g. PET and SPECT) and/or anatomic 3D volumes (e.g. CT and MR). This “fusion” of data may be viewed in a number of output formats including MIP and volume rendering.
syngo TrueD enables visualization of information that would otherwise have to be visually compared disjointedly. syngo TrueD provides analytical tools to help the user assess, and document any changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo TrueD is designed to support the oncological workflow by helping the user to confirm the absence or presence of lesions, including evaluation, quantification, follow-up and documentation of any such lesions.
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 TrueD is a complement to these standard procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041484 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041484: Undecided.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041484
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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