510(k) · Cleared
ClearedLung Nodule Assessment and Comparison Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Feb 10, 2003 as substantially equivalent to K961464 (Elscint, Inc., 1996) and 1 other predicate after a 90-day review. Its family tree reaches back 4 generations to 1993. 10 later devices descend from it.
- Decided
- Feb 10, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K930090 (1993). 9 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK930090 HelicatElscint, Inc. · 1993
- 3 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 2 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 1 generation backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- This deviceK023785 Lung Nodule Assessment and Comparison OptionPhilips Medical Systems (Cleveland), Inc. · 2003
- Descendant · cites it directly · 7 of its ownK162484 Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V. · 2017
- Descendant · 2 generations on · 1 of its ownK202990 NinesMeasureNines, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK193220 Aview LCSCoreline Soft Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK240554 InferRead Lung CT.AIInfervision Medical Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK240740 qCT LN QuantQure.Ai Technologies · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K162484Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V. · 2017 · cites it directly7descendants
- K202990NinesMeasureNines, Inc. · 2021 · 2 generations on1descendant
- K193220Aview LCSCoreline Soft Co., Ltd. · 2020 · 2 generations on1descendant
- K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K240740qCT LN QuantQure.Ai Technologies · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −3 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −2 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −1 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| 0 (this device) | K023785 | Lung Nodule Assessment and Comparison Option | Philips Medical Systems (Cleveland), Inc. | 2003 | — |
| +1 | K162484 | Lung Nodule Assessment and Comparison Option (LNA) | Philips Medical Systems Nederland B.V. | 2017 | — |
| +2 | K202990 | NinesMeasure | Nines, Inc. | 2021 | — |
| +2 | K193220 | Aview LCS | Coreline Soft Co., Ltd. | 2020 | — |
| +2 | K240554 | InferRead Lung CT.AI | Infervision Medical Technology Co., Ltd. | 2025 | — |
| +2 | K240740 | qCT LN Quant | Qure.Ai Technologies | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 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 |
|---|---|---|---|
| * | K961464 | Select/SPSummary page 2…lly equivalent to the legally marketed devices currently in commercial distribution, namely the Image Processing Function on the Select CT/SP in CDRH Document Control No K961464 and KO12009. See Appendix “G’,Equivalent Device Comparison Matrix. This opinion is based on the fact that comparing the Image Pro… | 1996 |
| * | K012009 | MX8000 Idt CT System | 2001 |
| * | — | Image Processing Function on the Mx8000IDT Named without a submission number |
What descends from it? (10)
3 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 10 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K162484 (Philips Medical Systems Nederland B.V., 2017) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K961464.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
The Philips Medical Systems MxView Lung Nodule Assessment and Comparison Option is intended for use as a diagnostic patient-imaging tool. It is intended to provide quantitative information about physician-indicated lung nodules that are identified on high-resolution computed tomography images of the lung.
The Lung Nodule Assessment and Comparison Option is used in a workstation (MxView) of a Computed Tomography X-Ray System intended to produce cross-sectional images of the lungs by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023785 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023785: Lung Nodule Assessment and Comparison Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023785
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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