Devices · Hologic Inc.

“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”

Hologic Inc. is listed for “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm” (DEN210035). The FDA list gives January 31, 2024 as the date of the final decision. The lead panel is Pathology, and the database link on the FDA list is the De Novo pathway. openFDA describes product code QYV as “Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm”: 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. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN210035

Official FDA database record

Date of final decision

January 31, 2024

Company on the FDA list

Hologic Inc.

Lead panel

Pathology

Primary product code

QYV

openFDA device name for the code

Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

Device class

2

Regulation number

864.3900

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned