510(k) · Cleared
ClearedMulti-Modality Tumor Tracking (MMTT) application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederland B.V. · LLZ System, Image Processing, Radiological
Cleared on Dec 19, 2016 as substantially equivalent to K101749 (Siemens Medical Solutions, 2010) and 1 other predicate after a 56-day review. Its family tree reaches back 10 generations to 1991. 5 later devices descend from it.
- Decided
- Dec 19, 2016
- Review
- 56 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K913770 (1991). 102 ancestors in all, the oldest K871859 (1987). 5 later devices descend from it, 2 citing it directly.
- 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 backK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- This deviceK162955 Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. · 2016
- Descendant · cites it directly · 3 of its ownK210831 OnQ NeuroCortechs Labs, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK250416 GBrain MRIGalileo Cds, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK252261 InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK252362 GBrain MRIGalileo Cds, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK240680 CDM InsightsOxford Brain Diagnostics, Ltd. · 2024
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 backK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- This deviceK162955 Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. · 2016
Most influential descendants
Showing 5 of 5 · See all- K210831OnQ NeuroCortechs Labs, Inc. · 2021 · cites it directly3descendants
- K250416GBrain MRIGalileo Cds, Inc. · 2025 · 2 generations on1descendant
- K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd. · 2026 · cites it directly0descendants
- K252362GBrain MRIGalileo Cds, Inc. · 2025 · 3 generations on0descendants
- K240680CDM InsightsOxford Brain Diagnostics, Ltd. · 2024 · 2 generations on0descendants
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 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| 0 (this device) | K162955 | Multi-Modality Tumor Tracking (MMTT) application | Philips Medical Systems Nederland B.V. | 2016 | — |
| +1 | K210831 | OnQ Neuro | Cortechs Labs, Inc. | 2021 | — |
| +2 | K250416 | GBrain MRI | Galileo Cds, Inc. | 2025 | — |
| +1 | K252261 | InferCare RECIST | Beijing Infervision Healthcare Medical Technology Co., Ltd. | 2026 | — |
| +3 | K252362 | GBrain MRI | Galileo Cds, Inc. | 2025 | — |
| +2 | K240680 | CDM Insights | Oxford Brain Diagnostics, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 10 | 0 |
| 2002 | 10 | 0 |
| 2003 | 3 | 0 |
| 2004 | 11 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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.
Planning a device in LLZ? 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 |
|---|---|---|---|
| * | K101749 | Syngo Trued SoftwareSummary page 7…Clearance Primary Siemens Medical August 16, Syngo TrueD K101749 predicate Solution 2010 Philips Medical P… | 2010 |
| * | K111336 | EBW NM 2.0Summary page 7…icate Solution 2010 Philips Medical Predicate EBW NM 2.0 TT K111336 May 24, 2011 Systems The proposed Philips Medical Systems Multi-Modality Tumo… | 2011 |
| † | K151353 | syngo.MR Neurology, syngo.MR Oncology | 2015 |
| † | K123920 | Syngo.Via | 2013 |
| † | K113620 | Myrian 1.11 | 2012 |
| † | K160315 | I4 (Integrated Intelligent Imaging Informatics) system | 2016 |
| † | K150665 | Philips Spectral CT Applications | 2015 |
| † | K023785 | Lung Nodule Assessment and Comparison Option | 2003 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 24 of the 102 ancestors have a recall of any class.
- Of its descendants, K210831 (Cortechs Labs, Inc., 2021) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K101749.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Multi-Modality Tumor Tracking (MMTT) application is a post processing software application used to display, process, analyze, quantify and manipulate anatomical and functional images, for CT, MR PET/CT and SPECT/CT images and/or multiple time-points. The MMTT application is intended for use on tumors which are known/confirmed to be pathologically diagnosed cancer. The results obtained may be used as a tool by clinicians in determining the diagnosis of patient disease conditions in various organs, tissues, and other anatomical structure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162955 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162955: Multi-Modality Tumor Tracking (MMTT) application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162955
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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