510(k) · Cleared
ClearedAdvanced Lung Analysis II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems · OEB Lung Computed Tomography System, Computer-Aided Detection
Cleared on Nov 18, 2004 as substantially equivalent to K013381 (General Electric Co., 2001) and 1 other predicate after a 49-day review. Its family tree reaches back 5 generations to 1991. 1 of the 213 devices in its family, counting itself, has a Class I recall. 207 later devices descend from it.
- Decided
- Nov 18, 2004
- Review
- 49 days
- Class
- Class II
- Product code
- OEB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K913770 (1991). 207 later devices descend from it, 3 citing it directly. 1 of the 213 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 deviceK042694 Advanced Lung Analysis IIGE Medical Systems · 2004
- Descendant · cites it directly · 204 of its ownK063324 Pet VcarGE Healthcare · 2007 · Recalled
- Descendant · 2 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 3 generations on · 76 of its ownK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
- Descendant · 3 generations on · 70 of its ownK101228 Mirada XDMirada Medical, Ltd. · 2010
- Descendant · 4 generations on · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
Showing 5 of 207 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…7 generations on · 2025
Most influential descendants
Showing 5 of 207 · See all- K063324Pet VcarGE Healthcare · 2007 · cites it directly204descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 2 generations on200descendants
- K101749Syngo Trued SoftwareSiemens Medical Solutions · 2010 · 3 generations on76descendants
- K101228Mirada XDMirada Medical, Ltd. · 2010 · 3 generations on70descendants
- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · 4 generations on63descendants
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) | K042694 | Advanced Lung Analysis II | GE Medical Systems | 2004 | — |
| +1 | K063324 | Pet Vcar | GE Healthcare | 2007 | 1 |
| +2 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +3 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
| +3 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| +4 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 7 | 0 |
| 2016 | 8 | 0 |
| 2017 | 9 | 0 |
| 2018 | 15 | 0 |
| 2019 | 13 | 0 |
| 2020 | 20 | 0 |
| 2021 | 14 | 0 |
| 2022 | 21 | 0 |
| 2023 | 17 | 0 |
| 2024 | 18 | 0 |
| 2025 | 22 | 1 |
| 2026 | 22 | 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 OEB device
- #1 K254075 Synapse Lung Nodule AIscore 14.4 · 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 |
|---|---|---|---|
| * | K013381 | Advanced Lung Analysis-1Summary page 1…ed below: * Model: Advanced Lung Analysis I , Manufacturer: General Electric Medical Systems, Buc - France 510(k)#: K013381 * Model: LungCare CT * Manufacturer: Siemens, Malvern - PA 19355 510(k) #: K… | 2001 |
| * | K033374 | Lungcare CT Software Package with Extended FunctionalitySummary page 1…ance 510(k)#: K013381 * Model: LungCare CT * Manufacturer: Siemens, Malvern - PA 19355 510(k) #: K033374 1/3 Device Description: Kb z CT Advanc… | 2003 |
What descends from it? (207)
See all 2073 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 7 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.
- None of the 5 ancestors has a recall.
- Of its descendants, K063324 (GE Healthcare, 2007) has gone furthest, with 204 descendants of its own.
- 6 other devices also cite its predicate K013381.
How does its category compare?
All OEB devicesOEB Lung Computed Tomography System, Computer-Aided Detection: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OEB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OEB
229in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OEB
No recall names OEB since 2007.
Adverse event reports per year · OEB
No MAUDE report names OEB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 3 | 229 | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Advanced Lung Analysis" is intended to provide an optimized non-invasive application to measure abnormalities in the lung (for example, nodules, lesions, etc.) from a set of Computed Tomography (CT) images. The software is designed to support the physician in confirming the presence or absence of physician identified lung lesions (e.g. nodules). The software allows measurement of volume over time using a consistent standardized measurement protocol, thus…
Read the full statement (175 words)
Advanced Lung Analysis" is intended to provide an optimized non-invasive application to measure abnormalities in the lung (for example, nodules, lesions, etc.) from a set of Computed Tomography (CT) images.
The software is designed to support the physician in confirming the presence or absence of physician identified lung lesions (e.g. nodules). The software allows measurement of volume over time using a consistent standardized measurement protocol, thus providing an estimation of the volume doubling time. ALA II software allows analysis and displays statistics for nodule characterization all the different nodule types.
ALA II optional Digital Contrast Agent (DCA) module is an automated highlight feature for the visual identification of possible lesions. Digital Contrast Agent (DCA) is a 3D filter that produces images that highlight spherical (8) and cylindrical (C) anatomical regions, such as nodules, cysts, scars, and vessels. Images are made available to the physician to aid in characterization of suspicious nodules and thus, the patient management care decision process.
ALA II provides to physician with additional information, meant to complement diagnosis based on classical techniques.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042694: Advanced Lung Analysis II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042694
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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