Hologic, Inc. radiology AI products

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FDA-cleared K243341

Genius AI Detection 2.0

Hologic, Inc.

Authorized purpose: Genius AI Detection 2.0 analyzes compatible digital breast tomosynthesis exams to identify and mark soft-tissue densities (masses, architectural distortions, asymmetries) and calcifications, providing lesion location/outline, confidence or Certainty of Findings, and a case score for concurrent review; the interpreting physician confirms or dismisses findings.

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2025-07-31

Breast imaging Detection and CADe

FDA-cleared K230096

Genius AI Detection 2.0 with CC-MLO Correlation

Hologic, Inc.

Authorized purpose: Provides CADe/CADx for compatible DBT examinations by marking breast masses, distortions/asymmetries, and calcifications for concurrent physician interpretation.

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2023-05-23

Breast imaging Detection and CADe

FDA-cleared K221449

Genius AI Detection 2.0

Hologic, Inc.

Authorized purpose: Genius AI Detection 2.0 analyzes compatible digital breast tomosynthesis images to identify and mark soft-tissue densities and calcifications with confidence scores and case scoring for concurrent physician interpretation.

Modality: Mammography/DBT
Anatomy: Breast; soft-tissue densities, architectural distortions or asymmetries, and calcifications
Decision: 2022-10-06

Breast imaging Detection and CADe

FDA-cleared K201019

Genius AI Detection

Hologic, Inc.

Authorized purpose: Genius AI Detection analyzes compatible digital breast tomosynthesis images to identify and mark soft-tissue densities and calcifications with confidence scores and case scoring for concurrent physician interpretation.

Modality: Mammography/DBT
Anatomy: Breast; soft-tissue densities and calcifications in digital breast tomosynthesis
Decision: 2020-11-18

Breast imaging Detection and CADe

FDA-cleared K163623

Quantra

HOLOGIC, INC.

Authorized purpose: Quantra 2.2 analyzes digital breast X-ray images and categorizes breast density to provide additional information for a radiologist's assessment.

Modality: Mammography/DBT
Anatomy: Breast; mammographic breast-density composition
Decision: 2017-10-20

Breast imaging Quantification and segmentation

FDA-cleared K142037

QUANTRA

HOLOGIC, INC.

Authorized purpose: Quantra version 2.1 calculates volumetric and area breast-density measures and density categories from supported digital mammography images as an adjunct, not a diagnostic result.

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2014-10-10

Breast imaging Quantification and segmentation

FDA-cleared K082483

QUANTRA

HOLOGIC, INC.

Authorized purpose: Quantra version 1.1 calculates a volumetric breast-density ratio from supported Hologic full-field digital mammography images on the Cenova server as an adjunct, not a diagnostic result.

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2008-09-12

Breast imaging Quantification and segmentation

FDA-approved P970058

M1000 IMAGECHECKER

Hologic, Inc.

Authorized purpose: The ImageChecker M1000 is a computer system intended to identify and mark regions of interest on routine screening mammograms after the initial reading has been completed, bringing them to the radiologist's attention and helping minimize observational oversights by identifying areas that may warrant a second review.

Modality: Mammography/DBT
Anatomy: Breast / routine screening mammograms
Decision: 1998-06-26

Breast imaging