Hologic, Inc.
5 AI-enabled device listings under this company name on the FDA list. The name is copied as published. It is not a review of the company.
| Date | Submission | Device | Panel | Code |
|---|---|---|---|---|
| July 31, 2025 | K243341 | Genius AI Detection 2.0 | Radiology | QDQ |
| May 23, 2023 | K230096 | Genius AI Detection 2.0 with CC-MLO Correlation | Radiology | QDQ |
| October 6, 2022 | K221449 | Genius AI Detection 2.0 | Radiology | QDQ |
| November 18, 2020 | K201019 | Genius AI Detection | Radiology | QDQ |
| June 26, 1998 | P970058 | M1000 IMAGECHECKER | Radiology | MYN |