510(k) · Cleared
ClearedCA-1500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
R2 Technology, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jan 22, 2004 as substantially equivalent to K023003 (R2 Technology, Inc., 2002) and 2 other predicates after a 14-day review. Its family tree reaches back 4 generations to 1991. 4 later devices descend from it.
- Decided
- Jan 22, 2004
- Review
- 14 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K913770 (1991). 10 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- 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 deviceK040028 CA-1500R2 Technology, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK060378 VITREA2 Version 3.8.1Vital Images, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK201501 VeolityMeVis Medical Solutions AG · 2021
- Descendant · 2 generations on · 0 of its ownK120161 Alphapoint Imaging SoftwareRadlogics, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK070868 LMS-Lung/TrackMedian Technologies · 2007
Most influential descendants
Showing 4 of 4 · See all- K060378VITREA2 Version 3.8.1Vital Images, Inc. · 2006 · cites it directly1descendant
- K201501VeolityMeVis Medical Solutions AG · 2021 · cites it directly0descendants
- K120161Alphapoint Imaging SoftwareRadlogics, Inc. · 2012 · 2 generations on0descendants
- K070868LMS-Lung/TrackMedian Technologies · 2007 · cites it directly0descendants
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) | K040028 | CA-1500 | R2 Technology, Inc. | 2004 | — |
| +1 | K060378 | VITREA2 Version 3.8.1 | Vital Images, Inc. | 2006 | — |
| +1 | K201501 | Veolity | MeVis Medical Solutions AG | 2021 | — |
| +2 | K120161 | Alphapoint Imaging Software | Radlogics, Inc. | 2012 | — |
| +1 | K070868 | LMS-Lung/Track | Median Technologies | 2007 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2021 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 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 |
|---|---|---|---|
| * | K023003 | Imagechecker-CT WorkstationSummary page 1…Classification ImageChecker CT R2 Technology Inc. K023003 LLZ, Class II Workstation Advanced Lung General Electric K013381… | 2002 |
| * | K013381 | Advanced Lung Analysis-1Summary page 1…R2 Technology Inc. K023003 LLZ, Class II Workstation Advanced Lung General Electric K013381 JAK, Class II Analysis- I Medical Systems _________________ Lung… | 2001 |
| * | K022013 | Lungcare CT Software PackageSummary page 1…JAK, Class II Analysis- I Medical Systems _________________ LungCARE C~T -Siemens Medical K022013 JAK., Class II Software Package Solutions_________ Device Description: The C-C… | 2002 |
What descends from it? (4)
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 13 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K060378 (Vital Images, Inc., 2006) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K023003.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The Comprehensive Chest Analysis Tools (C-CAT) package consists of software that
enables radiologists to view, analyze, register and compare new and previous series of
thoracic CT images. The software package assists the radiologists by calculating volume
change and doubling time of selected segmented candidate thoracic abnormalities, such
as pulmonary and pleural nodules and lesions, found on these images.
The software is designed to assist the radiologists in characterization and classification of
these suspicious candidate thoracic abnormalities in terms of size, dimension, shape and
position and thus aid in the patient management care decision process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040028 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040028: CA-1500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040028
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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