FDA-cleared K163623
Quantra
HOLOGIC, INC.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2017-10-20
Vendor
HOLOGIC, INC.
5 FDA-backed listings in this directory.
Claim vendor profile FDA-cleared K201019
Genius AI Detection
Hologic, Inc.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2020-11-18
FDA-cleared K221449
Genius AI Detection 2.0
Hologic, Inc.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2022-10-06
FDA-cleared K230096
Genius AI Detection 2.0 with CC-MLO Correlation
Hologic, Inc.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2023-05-23
FDA-cleared K243341
Genius AI Detection 2.0
Hologic, Inc.
Image analysis/processing.
- Modality
- Mammography/DBT
- Anatomy
- N/A
- Decision
- 2025-07-31