Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
The digital cervical cytology slide imaging system with artificial intelligence algorithm (product code QYV) is a Class 2 Pathology prescription in vitro diagnostic device (regulation 864.3900) consisting of an automated digital slide creation, viewing, and management system that uses AI and machine learning to analyze digital images of Pap test specimens and conventional Pap smears, selecting and presenting areas of interest to facilitate cytological interpretation and aid in rendering a cytology diagnosis. It requires 510(k) clearance. It is not an implant and is not life-sustaining.
Research product code QYV in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- QYV
- Device Class
- FDA class 2
- Regulation Number
- 864.3900
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN210035 | Genius Digital Diagnostics System with the Genius Cervical AI algorithm | Jan 31, 2024 | Unknown | Hologic, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.