510(k) · Cleared
ClearedVessel Analysis and Autoplaque for Ors Visual
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Object Research Systems (Ors), Inc. · LLZ System, Image Processing, Radiological
Cleared on Nov 28, 2012 as substantially equivalent to K092747 (Philips Medical Systems (Cleveland), Inc., 2009) and 2 other predicates after a 111-day review. Its family tree reaches back 10 generations to 1991. 16 later devices descend from it.
- Decided
- Nov 28, 2012
- Review
- 111 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K913770 (1991). 67 ancestors in all, the oldest K871859 (1987). 16 later devices descend from it, 6 citing it directly.
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations between
- 3 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 2 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 1 generation backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- This deviceK122429 Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc. · 2012
- Descendant · cites it directly · 7 of its ownK190868 Cleerly LabsCleerly, Inc. · 2019
- Descendant · 2 generations on · 5 of its ownK202280 Cleerly Labs v2.0Cleerly, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK212758 AutoplaqueCedars-Sinai Medical Center: Aim · 2023
- Descendant · 3 generations on · 2 of its ownK242338 Cleerly LABS (v2.0)Cleerly, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK242240 CaRi-PlaqueCaristo Diagnostics, Ltd. · 2025
Show all 10 generations
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 8 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 7 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 6 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 5 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 4 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 3 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 2 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 1 generation backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- This deviceK122429 Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc. · 2012
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K190868Cleerly LabsCleerly, Inc. · 2019 · cites it directly7descendants
- K202280Cleerly Labs v2.0Cleerly, Inc. · 2020 · 2 generations on5descendants
- K212758AutoplaqueCedars-Sinai Medical Center: Aim · 2023 · cites it directly3descendants
- K242338Cleerly LABS (v2.0)Cleerly, Inc. · 2025 · 3 generations on2descendants
- K242240CaRi-PlaqueCaristo Diagnostics, Ltd. · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −9 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −8 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −7 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −6 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −5 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −4 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −3 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −2 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −1 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| 0 (this device) | K122429 | Vessel Analysis and Autoplaque for Ors Visual | Object Research Systems (Ors), Inc. | 2012 | — |
| +1 | K190868 | Cleerly Labs | Cleerly, Inc. | 2019 | — |
| +2 | K202280 | Cleerly Labs v2.0 | Cleerly, Inc. | 2020 | — |
| +1 | K212758 | Autoplaque | Cedars-Sinai Medical Center: Aim | 2023 | — |
| +3 | K242338 | Cleerly LABS (v2.0) | Cleerly, Inc. | 2025 | — |
| +2 | K242240 | CaRi-Plaque | Caristo Diagnostics, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K092747 | Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolSummary page 2…oplaque add-on for ORS Visual is substantially equivalent to other commercially available products, specifically: * Philips' Comprehensive Cardiac Analysis (CCA) Plaque (K092747) * Vitrea Version 4.0 with SUREPlaque (K071331) Feature ORS Visual SUIREPla… | 2009 |
| * | K071331 | Vitrea Version 4.0Summary page 2…equivalent to other commercially available products, specifically: * Philips' Comprehensive Cardiac Analysis (CCA) Plaque (K092747) * Vitrea Version 4.0 with SUREPlaque (K071331) Feature ORS Visual SUIREPlaque Philips ____________Auto… | 2007 |
| * | K060779 | Advance Vessel Analysis IISummary page 6…ves that Vessel Analysis add-on for OR5 Visual is substantially equivalent to other commercially available products, specifically: * GE Advanced Vessel Analysis 11(K060779) * Vital Images Vitrea 4.0 (Vessel probe) (K071331) Feature ORS Visual AVA 1l… | 2006 |
What descends from it? (16)
See all 166 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 21 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 15 of the 67 ancestors have a recall of any class.
- Of its descendants, K190868 (Cleerly, Inc., 2019) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K092747.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Vessel Analysis is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. Vessel Analysis is a post processing application option for the ORS Visual (K1 00335) platform family of products and can be used in the analysis of 20/3D CT Angiography images/data derived from DICOM 3.0 compliant CT scans for the purpose…
Read the full statement (303 words)
Vessel Analysis is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images.
Vessel Analysis is a post processing application option for the ORS Visual (K1 00335) platform family of products and can be used in the analysis of 20/3D CT Angiography images/data derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular and vascular disease assessment. This software is designed to support the physician in assessment of stenosis analysis, pre/post stent procedure and directional vessel tortuosity visualization.
Vessel Analysis automatic visualization tools provide the users with the capabilities to facilitate segmentation of bony structures for accurate identification of the vessels. Once vessels are visualized, tools are available for sizing the vessel, analyzing calcified and non-calcified plaque to determine the densities of plaque within a coronary artery, measure areas of abnormalities within a vessel.
The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by people who have been appropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views make use of interpolated data. This is data that is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathology that is near or smaller than the scanning resolution may be present.
ORS Visual software (Kl100335) and the Vessel Analysis add-on must be installed on a suitable commercial computer platform. it is the user's responsibility to ensure the monitor quality and ambient light conditions are consistent with the clinical applications. Typical users of Vessel Analysis and ORS Visual (Kl 00335) are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122429 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122429: Vessel Analysis and Autoplaque for Ors Visual.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122429
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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