Clearance Summary
Genius Digital Diagnostics System with the Genius Cervical AI algorithm received FDA 510(k) clearance under submission number DEN210035, sponsored by Hologic, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 2024-01-31.
- Submission: DEN210035
- Applicant / Sponsor: Hologic, Inc.
- Clearance pathway: Direct
- Review panel: Pathology
- Device class: Class II
- Regulation citation: 21 CFR 864.3900
- Decision date: 2024-01-31
Classification & Regulation
This clearance is catalogued under FDA product code QYV and 21 CFR 864.3900, within the Pathology review panel as a Class II device.