510(k) DEN210035
DEN210035 is an FDA 510(k) premarket notification submitted by Hologic, Inc. for the device "Genius Digital Diagnostics System with the Genius Cervical AI algorithm". The FDA issued a decision of De Novo Granted on January 31, 2024. The device falls under product code QYV (Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm), a Class II device regulated under 21 CFR 864.3900. Hologic, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- January 31, 2024
- Date Received
- August 27, 2021
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
- Device Class
- Class II
- Regulation Number
- 864.3900
- Review Panel
- PA
- Submission Type
The digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm is a prescription in vitro diagnostic device consisting of an automated digital slide creation, viewing, and management system intended to aid in the review of digital images of slides prepared from Pap test specimens and conventional Pap smears by selecting and presenting areas of interest to facilitate interpretation by the reader. The AI software algorithm uses machine learning techniques to provide information to the user about the presence, location, or characteristics of areas of the image with clinical implications. Information from this device is intended to assist the user in rendering a cytology diagnosis.