510(k) · Cleared
ClearedImagechecker-CT Software Package with Filling Defect Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R2 Technology, Inc. · OEB Lung Computed Tomography System, Computer-Aided Detection
Cleared on Jun 8, 2004 as substantially equivalent to K033374 (Siemens AG Medical Solutions, 2003) and 1 other predicate after a 14-day review. Its family tree reaches back 5 generations to 1991. 3 later devices descend from it.
- Decided
- Jun 8, 2004
- Review
- 14 days
- Class
- Class II
- Product code
- OEB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K913770 (1991). 11 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- 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 deviceK041380 Imagechecker-CT Software Package with Filling Defect IndicatorR2 Technology, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK060378 VITREA2 Version 3.8.1Vital Images, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK120161 Alphapoint Imaging SoftwareRadlogics, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK042408 Iqqa-Chest Software PackageEdda Technology, Inc. · 2004
Most influential descendants
Showing 3 of 3 · See allView 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) | K041380 | Imagechecker-CT Software Package with Filling Defect Indicator | R2 Technology, Inc. | 2004 | — |
| +1 | K060378 | VITREA2 Version 3.8.1 | Vital Images, Inc. | 2006 | — |
| +2 | K120161 | Alphapoint Imaging Software | Radlogics, Inc. | 2012 | — |
| +1 | K042408 | Iqqa-Chest Software Package | Edda Technology, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 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 OEB? 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 |
|---|---|---|---|
| * | K033374 | Lungcare CT Software Package with Extended FunctionalitySummary page 1…Predicate Devices: Product Company _ 510(k) Number LungCARE CT Siemens Medical K033374 software package with Solutions extended functionality ImageChecker CT R2 Technology, Inc.… | 2003 |
| * | K023003 | Imagechecker-CT WorkstationSummary page 1…Medical K033374 software package with Solutions extended functionality ImageChecker CT R2 Technology, Inc. K023003 Workstation Device Description: The ImageChecker CT Software Package with Filling Defect Indicator (FDI), the subject of t… | 2002 |
What descends from it? (3)
2 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 13 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K060378 (Vital Images, Inc., 2006) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K033374.
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?
The ImageChecker CT Software Package with Filling Defect Indicator (FDI) is used during the review of contrast-enhanced computed tomography (CT) images of the chest. This software tool enables the radiologist to view and analyze regions of the image containing low density within vascular structures that may be indicative of filling defects or other intravascular abnonualities.
The software is designed to assist the radiologist in characterization and classification of these suspicious candidate thoracic abnonualities in tenus of density, size, dimension, shape and position, thus aiding in the patient management care decision process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041380 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041380: Imagechecker-CT Software Package with Filling Defect Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041380
Report an extraction error
Are you the manufacturer?
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