510(k) · Cleared
ClearedCleerly LABS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleerly, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jul 29, 2026 as substantially equivalent to K242338 (Cleerly, Inc., 2025) after a 159-day review. Its family tree reaches back 14 generations to 1991.
- Decided
- Jul 29, 2026
- Review
- 159 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K913770 (1991). 71 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 14 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations between
- 3 generations backK190868 Cleerly LabsCleerly, Inc. · 2019
- 2 generations backK202280 Cleerly Labs v2.0Cleerly, Inc. · 2020
- 1 generation backK242338 Cleerly LABS (v2.0)Cleerly, Inc. · 2025
- This deviceK260588 Cleerly LABSCleerly, Inc. · 2026
Show all 14 generations
- Root · 14 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 13 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 12 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 11 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 10 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 9 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 8 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 7 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 6 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 5 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 4 generations backK122429 Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc. · 2012
- 3 generations backK190868 Cleerly LabsCleerly, Inc. · 2019
- 2 generations backK202280 Cleerly Labs v2.0Cleerly, Inc. · 2020
- 1 generation backK242338 Cleerly LABS (v2.0)Cleerly, Inc. · 2025
- This deviceK260588 Cleerly LABSCleerly, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −13 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −12 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −11 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −10 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −9 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −8 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −7 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −6 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −5 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| −4 | K122429 | Vessel Analysis and Autoplaque for Ors Visual | Object Research Systems (Ors), Inc. | 2012 | — |
| −3 | K190868 | Cleerly Labs | Cleerly, Inc. | 2019 | — |
| −2 | K202280 | Cleerly Labs v2.0 | Cleerly, Inc. | 2020 | — |
| −1 | K242338 | Cleerly LABS (v2.0) | Cleerly, Inc. | 2025 | — |
| 0 (this device) | K260588 | Cleerly LABS | Cleerly, Inc. | 2026 | — |
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 |
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 |
|---|---|---|---|
| * | K242338 | Cleerly LABS (v2.0)Summary page 5…Product Classification Class II, § 892.2050 Primary Product Code QIH Subsequent Product Code LLZ Submission Number K242338 4. Device Description Cleerly LABS is a cloud-based, software-only medical device platform that provides core capab… | 2025 |
| † | K261210 | Cleerly Plaque | 2026 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 6 companies; a new generation was cleared every 12 months on median.
- 15 of the 71 ancestors have a recall of any class.
- 1 other device also cites its predicate K242338.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
Cleerly LABS is a web-based software application intended to be used by trained medical professionals as an interactive tool for processing, analyzing and viewing cardiac computed tomography (CT) data to assess coronary anatomy in patients who have undergone Coronary Computed Tomography Angiography (CCTA) for the evaluation of coronary artery disease (CAD) or suspected CAD. This software post-processes CT images obtained from a CT scanner and provides…
Read the full statement (159 words)
Cleerly LABS is a web-based software application intended to be used by trained medical professionals as an interactive tool for processing, analyzing and viewing cardiac computed tomography (CT) data to assess coronary anatomy in patients who have undergone Coronary Computed Tomography Angiography (CCTA) for the evaluation of coronary artery disease (CAD) or suspected CAD.
This software post-processes CT images obtained from a CT scanner and provides tools for the measurement and visualization of coronary arteries. The software is not intended to replace the skill and judgment of a qualified medical practitioner and should only be used by medical professionals experienced in examining and evaluating cardiac CT images. 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260588: Cleerly LABS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260588
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026