| Decision | Number | Device | Company | Panel |
|---|---|---|---|---|
| 2025-07-31 | K243341 | Genius AI Detection 2.0 | Hologic, Inc. | Radiology |
| 2024-01-31 | DEN210035 | “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm” | Hologic Inc. | Pathology |
| 2023-05-23 | K230096 | Genius AI Detection 2.0 with CC-MLO Correlation | Hologic, Inc. | Radiology |
| 2022-10-06 | K221449 | Genius AI Detection 2.0 | Hologic, Inc. | Radiology |
| 2020-11-18 | K201019 | Genius AI Detection | Hologic, Inc. | Radiology |
| 2017-10-20 | K163623 | Quantra | HOLOGIC, INC. | Radiology |
| 2014-10-10 | K142037 | QUANTRA | HOLOGIC, INC. | Radiology |
| 2008-09-12 | K082483 | QUANTRA | HOLOGIC, INC. | Radiology |
| 1998-06-26 | P970058 | M1000 IMAGECHECKER | Hologic, Inc. | Radiology |