Product code QYV— Pathology
Genius Digital Diagnostics System with the Genius Cervical AI algorithm
- Classification name
- Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
- Device class
- Class 2
- Regulation
- 21 CFR 864.3900
- Advisory panel
- Pathology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QYV
FDA has cleared device under product code QYV, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code QYV
Recent clearances under product code QYV
Data sourced from openFDA. This site is unofficial and independent of the FDA.