Radiology · De Novo · 2025
Allix5
Clairity, Inc.. Granted by FDA on 30 May 2025 under submission DEN240047, product code SEZ (radiological software device to predict future breast cancer risk). What FDA's record says, in FDA's words.
Device record · DEN240047
- Device. Allix5DEVICE
- Company. Clairity, Inc.COMPANY
- Decision. 30 May 2025, De NovoDECISION
- Panel. RadiologyPANEL
- Product code. SEZ, Radiological Software Device To Predict Future Breast Cancer RiskCODE
- Regulation. 21 CFR 892.8500, Class IIREG
- Source. FDA database entry · decision document (22 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement, verbatim, from the decision document.
The Allix5 is indicated as follows: 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. De Novo Summary (DEN240047) 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.
The product code's definition, from FDA's classification record. A radiological software device to predict future breast cancer risk is a device that analyzes radiological images generated by breast imaging modalities and/or inputs derived from radiological images to provide qualified healthcare professionals with a prediction of the risk of future (incident) breast cancer. This device produces a numeric probability and/or risk category indicative of the patients future breast cancer risk from the time the analyzed images were acquired. This device is not intended to diagnose, detect, or inform the treatment of cancer. The output of this device is not intended to guide interpretation of imaging exams.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsan adjunct to the clinician, not a replacement
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code SEZ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SEZ, in Radiology, or granted in 2025. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.