510(k) · Cleared
ClearedLungcare CT Software Package with Extended Functionality
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens AG Medical Solutions · OEB Lung Computed Tomography System, Computer-Aided Detection
Cleared on Nov 6, 2003 as substantially equivalent to K022013 (Siemens Medical Solutions USA, Inc., 2002) after a 15-day review. Its family tree reaches back 4 generations to 1991. 1 of the 300 devices in its family, counting itself, has a Class I recall. 295 later devices descend from it.
- Decided
- Nov 6, 2003
- Review
- 15 days
- Class
- Class II
- Product code
- OEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K913770 (1991). 295 later devices descend from it, 5 citing it directly. 1 of the 300 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 3 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 2 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 1 generation backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- This deviceK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- Descendant · cites it directly · 222 of its ownK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- Descendant · 2 generations on · 221 of its ownK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- Descendant · cites it directly · 207 of its ownK042694 Advanced Lung Analysis IIGE Medical Systems · 2004
- Descendant · 2 generations on · 204 of its ownK063324 Pet VcarGE Healthcare · 2007 · Recalled
- Descendant · 3 generations on · 201 of its ownK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
Showing 5 of 295 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 295 · See all- K041484UndecidedSiemens Medical Solutions USA, Inc. · 2004 · cites it directly222descendants
- K053301Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006 · 2 generations on221descendants
- K042694Advanced Lung Analysis IIGE Medical Systems · 2004 · cites it directly207descendants
- K063324Pet VcarGE Healthcare · 2007 · 2 generations on204descendants
- K071950Syngo TruedSiemens Medical Solutions USA, Inc. · 2007 · 3 generations on201descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −3 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −2 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −1 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| 0 (this device) | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| +1 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +2 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| +1 | K042694 | Advanced Lung Analysis II | GE Medical Systems | 2004 | — |
| +2 | K063324 | Pet Vcar | GE Healthcare | 2007 | 1 |
| +3 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 5 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 9 | 0 |
| 2013 | 7 | 0 |
| 2014 | 7 | 0 |
| 2015 | 8 | 0 |
| 2016 | 11 | 0 |
| 2017 | 13 | 0 |
| 2018 | 19 | 0 |
| 2019 | 17 | 0 |
| 2020 | 25 | 0 |
| 2021 | 20 | 0 |
| 2022 | 27 | 0 |
| 2023 | 24 | 0 |
| 2024 | 26 | 0 |
| 2025 | 30 | 1 |
| 2026 | 30 | 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? (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 |
|---|---|---|---|
| * | K022013 | Lungcare CT Software Package | 2002 |
What descends from it? (295)
See all 2955 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 12 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K041484 (Siemens Medical Solutions USA, Inc., 2004) has gone furthest, with 222 descendants of its own.
- 5 other devices also cite its predicate K022013.
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?
LungCARE CT is a self-contained image analysis software package for evaluating CT volume data sets. Combining enhanced commercially available digital image processing tools with an optimized workflow and reporting tools, the software is designed to support the physician in confirming the presence or absence of physician identified lung lesions (eg. nodules) in addition to evaluation, documentation and foflow-up of any such lesions using standard or…
Read the full statement (148 words)
LungCARE CT is a self-contained image analysis software package for evaluating CT volume data sets. Combining enhanced commercially available digital image processing tools with an optimized workflow and reporting tools, the software is designed to support the physician in confirming the presence or absence of physician identified lung lesions (eg. nodules) in addition to evaluation, documentation and foflow-up of any such lesions using standard or low-dose spiral CT scanning. The LungCare CT Software Package with extended functionality contains modifications which support the user with a special workflow based on automated segmentation for the visual identification of possible lesions (Nodule enhanced Viewing).
This visualization tool allows for volumetric analysis of pUlmonary nodule or lesion size over time, helping the Physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue unambiguously having determined their size, dimensions, shape and position.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033374 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033374: Lungcare CT Software Package with Extended Functionality.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033374
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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