510(k) · Cleared
ClearedLung Nodule Assessment and Comparison Option (LNA)
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 Feb 23, 2017 as substantially equivalent to K151283 (Vital Images, Inc., 2015) and 1 other predicate after a 169-day review. Its family tree reaches back 8 generations to 1991. 7 later devices descend from it.
- Decided
- Feb 23, 2017
- Review
- 169 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K913770 (1991). 34 ancestors in all. 7 later devices descend from it, 6 citing it directly.
- Root · 8 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 6 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 5 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 4 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 3 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 2 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 1 generation backK151283 Lung Analysis SoftwareVital Images, Inc. · 2015
- This deviceK162484 Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V. · 2017
- Descendant · cites it directly · 1 of its ownK202990 NinesMeasureNines, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK193220 Aview LCSCoreline Soft Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK240554 InferRead Lung CT.AIInfervision Medical Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK240740 qCT LN QuantQure.Ai Technologies · 2024
- Descendant · cites it directly · 0 of its ownK221612 ClearRead CTRiverain Technologies, Inc. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K202990NinesMeasureNines, Inc. · 2021 · cites it directly1descendant
- K193220Aview LCSCoreline Soft Co., Ltd. · 2020 · cites it directly1descendant
- K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd. · 2025 · cites it directly0descendants
- K240740qCT LN QuantQure.Ai Technologies · 2024 · cites it directly0descendants
- K221612ClearRead CTRiverain Technologies, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −7 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −6 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −5 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −4 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −3 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −2 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −1 | K151283 | Lung Analysis Software | Vital Images, Inc. | 2015 | — |
| 0 (this device) | K162484 | Lung Nodule Assessment and Comparison Option (LNA) | Philips Medical Systems Nederland B.V. | 2017 | — |
| +1 | K202990 | NinesMeasure | Nines, Inc. | 2021 | — |
| +1 | K193220 | Aview LCS | Coreline Soft Co., Ltd. | 2020 | — |
| +1 | K240554 | InferRead Lung CT.AI | Infervision Medical Technology Co., Ltd. | 2025 | — |
| +1 | K240740 | qCT LN Quant | Qure.Ai Technologies | 2024 | — |
| +1 | K221612 | ClearRead CT | Riverain Technologies, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K151283 | Lung Analysis SoftwareSummary page 5…System, Image October JAK, 21CFR Class Analysis K151283 processing, Radiology… | 2015 |
| * | K023785 | Lung Nodule Assessment and Comparison OptionSummary page 5…System, Image Assessment Feb 10 90 21CFR Class K023785 processing, Radiology and… | 2003 |
| † | K153444 | Philips Multislice CT System with Low Dose CT Lung Cancer | 2016 |
| † | K060937 | Brilliance Volume | 2006 |
| † | K160315 | I4 (Integrated Intelligent Imaging Informatics) system | 2016 |
| † | K111336 | EBW NM 2.0 | 2011 |
What descends from it? (7)
6 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 26 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 34 ancestors have a recall of any class.
- Of its descendants, K202990 (Nines, Inc., 2021) has gone furthest, with 1 descendant of its own.
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 Lung Nodule Assessment and Comparison Option is intended for use as a diagnostic patient-imaging tool.
It is intended for the review and analysis of thoracic CT images, providing quantitative and characterizing information
about nodules in the lung in a single study, or over the time course of several thoracic studies. Characterizations include
diameter, volume and volume over time. The system automatically performs the measurements, allowing lung nodules
and measurements to be displayed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162484 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162484: Lung Nodule Assessment and Comparison Option (LNA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162484
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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