510(k) DEN210035
- Device
- “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”
- Applicant
- Hologic, Inc.
- 510(k) number
- DEN210035
- Product code
- QYV
- Decision
- Unknown (DENG)
- Decision date
- 2024-01-31
- Date received
- 2021-08-27
- Regulation
- 864.3900
- Classification name
- Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Bryce Dzialo
- Address
- 250 Campus Dr. Malborough MA US 01752 01752
FDA Registration Numbers#
- 1222780
- 3006330030
Source Documents#
510(k) summary PDF not indicated by FDA