510(k) · Cleared
ClearedLung Car 1.1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicsight · OEB Lung Computed Tomography System, Computer-Aided Detection
Cleared on Jul 22, 2004 as substantially equivalent to K033412 (Medicsight, 2003) and 2 other predicates after a 16-day review. Its family tree reaches back 5 generations to 1991. 1 of the 142 devices in its family, counting itself, has a Class I recall. 135 later devices descend from it.
- Decided
- Jul 22, 2004
- Review
- 16 days
- Class
- Class II
- Product code
- OEB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K913770 (1991). 6 ancestors in all. 135 later devices descend from it, 1 citing it directly. 1 of the 142 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 deviceK041807 Lung Car 1.1Medicsight · 2004
- Descendant · cites it directly · 134 of its ownK061214 Aquariusaps ServerTerarecon,Inc. · 2006
- Descendant · 2 generations on · 99 of its ownK112020 Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011
- Descendant · 3 generations on · 63 of its ownK123920 Syngo.ViaSiemens AG Medical Solutions · 2013
- Descendant · 4 generations on · 46 of its ownK150843 syngo®.via (version VB10A)Siemens AG · 2015
- Descendant · 5 generations on · 23 of its ownK163294 syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc. · 2017
Showing 5 of 135 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…6 generations on · 2025
Most influential descendants
Showing 5 of 135 · See all- K061214Aquariusaps ServerTerarecon,Inc. · 2006 · cites it directly134descendants
- K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc. · 2011 · 2 generations on99descendants
- K123920Syngo.ViaSiemens AG Medical Solutions · 2013 · 3 generations on63descendants
- K150843syngo®.via (version VB10A)Siemens AG · 2015 · 4 generations on46descendants
- K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc. · 2017 · 5 generations on23descendants
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) | K041807 | Lung Car 1.1 | Medicsight | 2004 | — |
| +1 | K061214 | Aquariusaps Server | Terarecon,Inc. | 2006 | — |
| +2 | K112020 | Syngo.CT Vascular Analysis | Siemens Medi Cal Solutions, Inc. | 2011 | — |
| +3 | K123920 | Syngo.Via | Siemens AG Medical Solutions | 2013 | — |
| +4 | K150843 | syngo®.via (version VB10A) | Siemens AG | 2015 | — |
| +5 | K163294 | syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology | Siemens Medical Solutions USA, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 8 | 0 |
| 2019 | 9 | 0 |
| 2020 | 14 | 0 |
| 2021 | 7 | 0 |
| 2022 | 12 | 0 |
| 2023 | 14 | 0 |
| 2024 | 14 | 0 |
| 2025 | 18 | 1 |
| 2026 | 15 | 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? (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 |
|---|---|---|---|
| * | K033412 | Mediclung, Release 1Summary page 1…Manufacturer Device 510(k) No. MEDICSIGHT MEDICLUNG 1.0 K033412 SIEMENS LUNGCARE CT (with extended functionality NEV) K033374 GE ADVANCED LUNG… | 2003 |
| * | K033374 | Lungcare CT Software Package with Extended FunctionalitySummary page 1…MEDICSIGHT MEDICLUNG 1.0 K033412 SIEMENS LUNGCARE CT (with extended functionality NEV) K033374 GE ADVANCED LUNG ANALYSIS K013381 Medicsight Lung CAR fNI 1.1 Special 5… | 2003 |
| * | K013381 | Advanced Lung Analysis-1Summary page 1…2 SIEMENS LUNGCARE CT (with extended functionality NEV) K033374 GE ADVANCED LUNG ANALYSIS K013381 Medicsight Lung CAR fNI 1.1 Special 510(k) submission… | 2001 |
What descends from it? (135)
See all 1351 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061214 | Aquariusaps Server | 2006 | 134 |
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 · 6 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 5 companies; a new generation was cleared every 1.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K061214 (Terarecon,Inc., 2006) has gone furthest, with 134 descendants of its own.
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?
Lung CAR 1.1 is a PC-based, stand-alone, non-invasive, image analysis software application for the display and visualization of 2D and 3D medical image data of the lung derived from CT scans, for the purpose of assisting radiologists and other clinicians in the evaluation of lung lesions (e.g. nodules). The software provides functionality for the user to extract the region of interest (ROI) either manually using a drawing tool, or "semi-automatically"…
Read the full statement (146 words)
Lung CAR 1.1 is a PC-based, stand-alone, non-invasive, image analysis software application for the display and visualization of 2D and 3D medical image data of the lung derived from CT scans, for the purpose of assisting radiologists and other clinicians in the evaluation of lung lesions (e.g. nodules). The software provides functionality for the user to extract the region of interest (ROI) either manually using a drawing tool, or "semi-automatically" through the user selecting either a single or double seed point followed by interactive fine-tuning the boundaries of the ROL Lung CAR 1.1 provides quantative information for measurement of lesion volume and other measured characteristics over time allowing the user to review and track any changes in the physician-indicated nodules or lesions.
Lung CAR 1.1 contains additional imaging tools which allow enhancement of specified features, and which the clinician can view simultaneously with the non-enhanced view.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041807 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041807: Lung Car 1.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041807
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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