510(k) · Cleared
ClearedCor Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rcadia Medical Imaging, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Jan 31, 2011 as substantially equivalent to K072242 (Rcadia Medical Imaging, Ltd., 2007) after a 21-day review. Its family tree reaches back 11 generations to 1991. 4 later devices descend from it.
- Decided
- Jan 31, 2011
- Review
- 21 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K913770 (1991). 32 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations between
- 3 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 2 generations backK063548 Cor Analyzer 1, Version 1.4Rcadia Medical Imaging, Ltd. · 2007
- 1 generation backK072242 Cor Analyzer II, Model V1.7Rcadia Medical Imaging, Ltd. · 2007
- This deviceK110071 Cor AnalyzerRcadia Medical Imaging, Ltd. · 2011
- Descendant · cites it directly · 3 of its ownK123646 Emory Cardiac Toolbox 4.0Syntermed, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK231731 Optional Screen Displays for HeartSee Cardiac P.E.T. Processing…Mcgovern Medical School · 2023
- Descendant · 3 generations on · 0 of its ownK243881 HeartSee™ Cardiac P.E.T. Processing Software For Myocardial…Bracco Diagnostics, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK223422 Emory Cardiac Toolbox 4.3Syntermed · 2023
Show all 11 generations
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 9 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 8 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 7 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 6 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 5 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 4 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 3 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 2 generations backK063548 Cor Analyzer 1, Version 1.4Rcadia Medical Imaging, Ltd. · 2007
- 1 generation backK072242 Cor Analyzer II, Model V1.7Rcadia Medical Imaging, Ltd. · 2007
- This deviceK110071 Cor AnalyzerRcadia Medical Imaging, Ltd. · 2011
Most influential descendants
Showing 4 of 4 · See all- K123646Emory Cardiac Toolbox 4.0Syntermed, Inc. · 2013 · cites it directly3descendants
- K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School · 2023 · 2 generations on1descendant
- K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc. · 2025 · 3 generations on0descendants
- K223422Emory Cardiac Toolbox 4.3Syntermed · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −10 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −9 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −8 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −7 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −6 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −5 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −4 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −3 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −2 | K063548 | Cor Analyzer 1, Version 1.4 | Rcadia Medical Imaging, Ltd. | 2007 | — |
| −1 | K072242 | Cor Analyzer II, Model V1.7 | Rcadia Medical Imaging, Ltd. | 2007 | — |
| 0 (this device) | K110071 | Cor Analyzer | Rcadia Medical Imaging, Ltd. | 2011 | — |
| +1 | K123646 | Emory Cardiac Toolbox 4.0 | Syntermed, Inc. | 2013 | — |
| +2 | K231731 | Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software -… | Mcgovern Medical School | 2023 | — |
| +3 | K243881 | HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and… | Bracco Diagnostics, Inc. | 2025 | — |
| +2 | K223422 | Emory Cardiac Toolbox 4.3 | Syntermed | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K072242 | Cor Analyzer II, Model V1.7Summary page 1…Class II Reason for 510(k) Submission Modification of legally marketed device - Special 510(K) Identification of Legially Marketed Predicate (un modified) Device K072242 COR Analyzer 11 Manufacturer: RCADIA Description of the Device Modifications The COR Analyzer (unmodified) device is… | 2007 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123646 | Emory Cardiac Toolbox 4.0 | 2013 | 3 |
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 20 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 7 of the 32 ancestors have a recall of any class.
- Of its descendants, K123646 (Syntermed, Inc., 2013) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 COR Analyzer is intended to assist a trained physician to analyze Computed Tomography (CT) Angiographic images. The device is not intended for use with mammography. The COR Analyzer is specifically indicated to provide visualization of the major coronary vesseis and lesions, thus assisting the physician in visualizing the coronary anatomy and pathology. COR Analyzer has abilities for coronary vessels segmentations, abnormalities display and processing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110071 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110071: Cor Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110071
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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