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QYVClass II

Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

21 CFR 864.3900 / Pathology
FDA source (opens on fda.gov)

QYV is the FDA product code for Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm, a class II device type, regulated under 21 CFR 864.3900. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
QYV
Device name
Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
FDA 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.
Regulation
21 CFR 864.3900
Device class
Class II
Review panel
Pathology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
1

Clearances, product code QYV

By decision year
1 clearance under product code QYV with a decision year between 2024 and 2024, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QYV by decision year
YearClearances
20241

Applicants with the most clearances

Product code QYV
Applicants holding the most 510(k) clearances under product code QYV
ApplicantClearances
Hologic, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code