510(k) · Cleared
ClearedArterys Oncology DL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arterys, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jan 25, 2018 as substantially equivalent to K101749 (Siemens Medical Solutions, 2010) after a 70-day review. Its family tree reaches back 10 generations to 1991. 5 later devices descend from it.
- Decided
- Jan 25, 2018
- Review
- 70 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K913770 (1991). 93 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 deviceK173542 Arterys Oncology DLArterys, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK182034 Arterys MICAArterys, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK192437 Arterys MICAArterys, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK203744 Arterys MICAArterys, Inc. · 2022
- Descendant · 4 generations on · 0 of its ownK252539 Tempus PixelArterys, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK192969 Ezra Plexo SoftwareEzra Ai, Inc. · 2020
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 deviceK173542 Arterys Oncology DLArterys, Inc. · 2018
Most influential descendants
Showing 5 of 5 · See all- K182034Arterys MICAArterys, Inc. · 2018 · cites it directly3descendants
- K192437Arterys MICAArterys, Inc. · 2020 · 2 generations on2descendants
- K203744Arterys MICAArterys, Inc. · 2022 · 3 generations on1descendant
- K252539Tempus PixelArterys, Inc. · 2025 · 4 generations on0descendants
- K192969Ezra Plexo SoftwareEzra Ai, Inc. · 2020 · cites it directly0descendants
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) | K173542 | Arterys Oncology DL | Arterys, Inc. | 2018 | — |
| +1 | K182034 | Arterys MICA | Arterys, Inc. | 2018 | — |
| +2 | K192437 | Arterys MICA | Arterys, Inc. | 2020 | — |
| +3 | K203744 | Arterys MICA | Arterys, Inc. | 2022 | — |
| +4 | K252539 | Tempus Pixel | Arterys, Inc. | 2025 | — |
| +1 | K192969 | Ezra Plexo Software | Ezra Ai, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 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 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 10 | 0 |
| 2002 | 10 | 0 |
| 2003 | 3 | 0 |
| 2004 | 9 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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? (1)
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 4…e LLZ Regulatory Class II 3. Predicate Device Proprietary Name syngoTM TrueD Premarket Notification K101749 Classification Name System, Image Processing, Radiological Regulation Number 21 CFR 892.2050… | 2010 |
| † | K163253 | Arterys Cardio DL | 2017 |
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 27 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 20 of the 93 ancestors have a recall of any class.
- Of its descendants, K182034 (Arterys, Inc., 2018) 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. 2018, 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?
Arterys Oncology DL is a medical diagnostic application for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering. Arterys Oncology DL enables visualization of information that would otherwise have to be visually compared…
Read the full statement (156 words)
Arterys Oncology DL is a medical diagnostic application for viewing, manipulation, 3D- visualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.
Arterys Oncology DL enables visualization of information that would otherwise have to be visually compared disjointedly. Arterys Oncology DL provides analytical tools to help the user assess and document changes in morphological activity at diagnostic and therapy follow-up examinations.
Arterys Oncology DL is designed to support the oncological workflow by helping the user 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. Arterys Oncology DL is a complement to these standard procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173542: Arterys Oncology DL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173542
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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