510(k) · Cleared
ClearedCleerly Labs v2.0
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 Oct 2, 2020 as substantially equivalent to K190868 (Cleerly, Inc., 2019) after a 52-day review. Its family tree reaches back 12 generations to 1991. 5 later devices descend from it.
- Decided
- Oct 2, 2020
- Review
- 52 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K913770 (1991). 69 ancestors in all, the oldest K871859 (1987). 5 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations between
- 3 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 2 generations backK122429 Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc. · 2012
- 1 generation backK190868 Cleerly LabsCleerly, Inc. · 2019
- This deviceK202280 Cleerly Labs v2.0Cleerly, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK242338 Cleerly LABS (v2.0)Cleerly, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK261210 Cleerly PlaqueCleerly, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK260588 Cleerly LABSCleerly, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK253786 syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK251656 Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd. · 2025
Show all 12 generations
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 11 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 10 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 9 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 8 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 7 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 6 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 5 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 4 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 3 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 2 generations backK122429 Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc. · 2012
- 1 generation backK190868 Cleerly LabsCleerly, Inc. · 2019
- This deviceK202280 Cleerly Labs v2.0Cleerly, Inc. · 2020
Most influential descendants
Showing 5 of 5 · See all- K242338Cleerly LABS (v2.0)Cleerly, Inc. · 2025 · cites it directly2descendants
- K261210Cleerly PlaqueCleerly, Inc. · 2026 · 2 generations on0descendants
- K260588Cleerly LABSCleerly, Inc. · 2026 · 2 generations on0descendants
- K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc. · 2026 · cites it directly0descendants
- K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −11 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −10 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −9 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −8 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −7 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −6 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −5 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −4 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −3 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| −2 | K122429 | Vessel Analysis and Autoplaque for Ors Visual | Object Research Systems (Ors), Inc. | 2012 | — |
| −1 | K190868 | Cleerly Labs | Cleerly, Inc. | 2019 | — |
| 0 (this device) | K202280 | Cleerly Labs v2.0 | Cleerly, Inc. | 2020 | — |
| +1 | K242338 | Cleerly LABS (v2.0) | Cleerly, Inc. | 2025 | — |
| +2 | K261210 | Cleerly Plaque | Cleerly, Inc. | 2026 | — |
| +2 | K260588 | Cleerly LABS | Cleerly, Inc. | 2026 | — |
| +1 | K253786 | syngo.CT Coronary Cockpit | Siemens Medical Solutions USA, Inc. | 2026 | — |
| +1 | K251656 | Careverse CoronaryDoc (Careverse CoronaryDoc) | Careverse Technology Pte., 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 |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K190868 | Cleerly LabsSummary page 4…LLZ 3. Predicate Device Information Table 3: Predicate Device Information Trade Name Cleerly Labs (K190868) Common Name System, Image Processing, Radiological Regulation Number 21 CFR 892.2050 Picture Archivi… | 2019 |
What descends from it? (5)
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 29 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 15 of the 69 ancestors have a recall of any class.
- Of its descendants, K242338 (Cleerly, Inc., 2025) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K190868.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 that is intended to be used by trained medical professionals as an interactive tool for viewing and analyzing cardiac computed tomography (CT) data for determining the presence and extent of coronary plaques (i.e., atherosclerosis) and stenosis in patients who underwent Coronary Computed Tomography Angiography (CCTA) for evaluation of CAD or suspected CAD. This software post processes CT images obtained…
Read the full statement (171 words)
Cleerly Labs is a web-based software application that is intended to be used by trained medical professionals as an interactive tool for viewing and analyzing cardiac computed tomography (CT) data for determining the presence and extent of coronary plaques (i.e., atherosclerosis) and stenosis in patients who underwent Coronary Computed Tomography Angiography (CCTA) for evaluation of CAD or suspected CAD. This software post processes CT images obtained using any Computed Tomography (CT) scanner. The software 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202280 · printed Nov 5, 2026
Cite this page
510(k) Report. “K202280: Cleerly Labs v2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202280
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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