510(k) · Cleared
ClearedcmAngio® V2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Curemetrix, Inc. · QIH Automated Radiological Image Processing Software
Cleared on Jul 30, 2026 after a 127-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 30, 2026
- Review
- 127 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
cmAngio, a proprietary artificial intelligence (Al)-based software is intended to process Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms to aid qualified interpreting physicians in the identification, visualization, and contextualization of Breast Arterial Calcifications (BAC), an incidental finding. The software functionalities include: * Detection of BAC at both the study and breast level, * Localization…
Read the full statement (171 words)
cmAngio, a proprietary artificial intelligence (Al)-based software is intended to process Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms to aid qualified interpreting physicians in the identification, visualization, and contextualization of Breast Arterial Calcifications (BAC), an incidental finding.
The software functionalities include:
* Detection of BAC at both the study and breast level,
* Localization of BAC segments by marking detected regions on image thumbnails,
* Measurement of Study-level BAC Length and View-level BAC Length, representing the extent of detected BAC findings.
* Normalization of BAC length and comparison against an age-matched Reference Library to report and display an Age-based BAC Percentile, and
* Reporting of Age-based BAC Prevalence based on the same Reference Library.
The software is intended to be used by qualified interpreting physicians in parallel with breast cancer screening mammography workflow. The device is not intended for primary interpretation of digital mammography images as used for breast cancer detection. The device results should not be used alone to make any diagnosis and/or treatment decisions.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260980 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260980: cmAngio® V2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260980
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026