“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”
FDA 510(k) clearance DEN210035 · decided 2024-01-31
Clearance details
- K-number
- DEN210035
- Device name
- “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”
- Applicant
- Hologic, Inc.
- Decision
- Unknown
- Date received
- 2021-08-27
- Decision date
- 2024-01-31
- Days to decision
- 887 days
- Clearance type
- Direct
- Product code
- QYV
- Device class
- 2
- Regulation number
- 864.3900
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Malborough, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Hologic
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NovaSure Model 10 RF Controller (P010013/S094) | Hologic, Inc. | 2025-12-17 |
| Envision Mammography Platform (P080003/S011) | Hologic, Inc. | 2025-11-24 |
| Aptima HBV Quant Assay Kit, 100T; Aptima HBV Quant Calibrator Kit; Aptima HBV Quant Controls Kit; Aptima HBV Quant Targe (P170025/S023) | Hologic, Inc. | 2025-10-07 |
| ThinPrep Processor and ThinPrep Imaging System (P950039/S041) | Hologic, Inc. | 2025-08-27 |
| Rapid fFN Cassette Kit for the TLiIQ System, Rapid fFN Control for the TLiIQ System (P920048/S027) | Hologic, Inc. | 2024-12-06 |
| TLiIQ QCette (P920048/S026) | Hologic, Inc. | 2024-10-23 |
| Aptima CMV Quant Assay (P210029/S002) | Hologic, Inc. | 2024-10-23 |
| Aptima HBV Quant Assay (P170025/S022) | Hologic, Inc. | 2024-10-23 |