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Allix5

by Clairity, Inc.

De Novo DEN240047

Active United States

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA De Novo, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Direct NumberDEN240047 Date30 May 2025DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA De Novo Active

Specification

De Novo

De Novo Number
FDA Product Code
SEZ
Device Class
Class II
Regulation
21 CFR Part 892.8500
Advisory Committee
Radiology
FDA Decision
DENG De Novo granted

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Allix5 is a radiological software device designed to predict future breast cancer risk. It analyzes bilateral screening mammogram imaging data at the pixel level to generate a 5-year risk prediction. The device calculates the percentage probability that an individual will receive a diagnosis of breast cancer or develop breast cancer within the 5-year timeframe following the screening.

Allix5 is supplied as a software device and is intended for use with mammography imaging data. It is authorized under FDA 510K clearance with product code SEZ. The device is classified as Class II and is regulated for use in radiology settings. No information regarding sterility, single-use or reusable status, MRI safety, or storage conditions is provided in the data.

Other devices from Clairity, Inc.

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Allix5 device used for?

    Allix5 is a radiological software device that analyzes bilateral screening mammogram imaging data at the pixel level to generate a 5-year risk prediction of breast cancer diagnosis or development.

  • How is the Allix5 device supplied?

    Allix5 is supplied as a software device intended for use with mammography imaging data. No information regarding physical packaging or sterility is provided in the device data.

  • What is the regulatory status of the Allix5 device?

    Allix5 is authorized under FDA 510K clearance with product code SEZ, classified as Class II, and regulated for use in radiology settings. The device received direct clearance type with decision code DENG.

  • What information does the Allix5 device provide?

    The device calculates the percentage probability that an individual will receive a diagnosis of breast cancer or develop breast cancer within the 5-year timeframe following the screening mammogram.