Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
QYV · Class II — Moderate Risk (510(k) clearance required) · Pathology · 21 CFR 864.3900
Classification
FDA Product Code
QYV
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 864.3900
Review panel
PA
Medical specialty
Pathology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.