De Novo · Granted
GrantedAllix5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clairity, Inc. · SEZ Radiological Software Device To Predict Future Breast Cancer Risk
Granted on May 30, 2025 as a new device type through De Novo after a 266-day review.
- Decided
- May 30, 2025
- Review
- 266 days
- Class
- Class II
- Product code
- SEZ
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo 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 SEZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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 SEZ devicesSEZ Radiological Software Device To Predict Future Breast Cancer Risk: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SEZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SEZ
Too few SEZ 510(k)s in any year since 2007 to give a median.
Recalls per year · SEZ
No recall names SEZ since 2007.
Adverse event reports per year · SEZ
No MAUDE report names SEZ since 2007.
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 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Clairity Allix5 software device is intended to generate a 5-year risk prediction of breast cancer based on a bilateral screening mammogram. Allix5 provides a prediction of the percentage probability that the individual will receive a diagnosis of breast cancer or develop breast cancer within the 5-year timeframe following the screening mammogram, through analysis of mammography features and characteristics. Eligible patients do not have a known…
Read the full statement (149 words)
The Clairity Allix5 software device is intended to generate a 5-year risk prediction of breast cancer based on a bilateral screening mammogram. Allix5 provides a prediction of the percentage probability that the individual will receive a diagnosis of breast cancer or develop breast cancer within the 5-year timeframe following the screening mammogram, through analysis of mammography features and characteristics.
Eligible patients do not have a known breast cancer at presentation for their screening mammogram.
Allix5 is not intended to diagnose or detect breast cancer, or to provide care recommendations. Allix5 is not intended to replace or to be used as the sole determinant for clinical decision-making. Allix5 output is intended to be considered after the radiologist has completed the interpretation of the screening mammogram.
Allix5 analyzes full-field digital mammograms or directly acquired 2D images from Hologic Lorad Selenia and Selenia Dimensions Mammography Systems; it does not analyze synthetic-2D images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN240047 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN240047: Allix5.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN240047
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026