The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Genius Ai Detection 2.0.
| Device ID | K221449 |
| 510k Number | K221449 |
| Device Name: | Genius AI Detection 2.0 |
| Classification | Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer |
| Applicant | Hologic, Inc. 250 Campus Drive Marlborough, MA 01730 |
| Contact | Deborah Thomas |
| Correspondent | Deborah Thomas Hologic, Inc. 250 Campus Drive Marlborough, MA 01730 |
| Product Code | QDQ |
| CFR Regulation Number | 892.2090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-18 |
| Decision Date | 2022-10-06 |