510(k) · Cleared
ClearedCleerly Plaque
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleerly, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Jul 29, 2026 as substantially equivalent to K242338 (Cleerly, Inc., 2025) after a 106-day review. Its family tree reaches back 14 generations to 1991.
- Decided
- Jul 29, 2026
- Review
- 106 days
- Class
- Class II
- Product code
- QIH
- 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 deviceK261210 Cleerly PlaqueCleerly, 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 deviceK261210 Cleerly PlaqueCleerly, 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) | K261210 | Cleerly Plaque | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 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 Plaque is a cloud-based, software-only module designed for use by medical professiona… | 2025 |
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 QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
Cleerly Plaque is a software module used in conjunction with Cleerly LABS, designed to assist in the evaluation of coronary artery disease (CAD) by identifying, characterizing, and quantifying coronary plaque in patients undergoing coronary computed tomography angiography (CCTA). 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…
Read the full statement (121 words)
Cleerly Plaque is a software module used in conjunction with Cleerly LABS, designed to assist in the evaluation of coronary artery disease (CAD) by identifying, characterizing, and quantifying coronary plaque in patients undergoing coronary computed tomography angiography (CCTA).
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 dataset. 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/K261210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261210: Cleerly Plaque.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261210
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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