FDA.reportPublic FDA data

De Novo DEN210035

Device
“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”
Contact
bryce dzialo
De Novo number
DEN210035
Product code
QYV
Regulation
864.3900
Classification name
digital cervical cytology slide imaging system with artificial intelligence algorithm
Decision
granted (DENG)
Decision date
2024-01-31
Date received
2021-08-27
Classification advisory
Pathology
Review advisory
Pathology
Type
Direct

Current FDA Classification#

Product code
QYV
Device name
Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
Medical specialty
Pathology
Device class
2
Regulation
864.3900
Implant
N
Life sustain/support
N