Devices · Clairity, Inc.

Allix5

Clairity, Inc. is listed for Allix5 (DEN240047). The FDA list gives May 30, 2025 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the De Novo pathway. openFDA describes product code SEZ as “Radiological Software Device To Predict Future Breast Cancer Risk”: 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 patient’s 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. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN240047

Official FDA database record

Date of final decision

May 30, 2025

Company on the FDA list

Clairity, Inc.

Lead panel

Radiology

Primary product code

SEZ

openFDA device name for the code

Radiological Software Device To Predict Future Breast Cancer Risk

Device class

2

Regulation number

892.8500

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned