FDA 510(k) Application Details - DEN210035

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN210035
Device Name	ôGeniusÖ Digital Diagnostics System with the GeniusÖ Cervical AI algorithmö
Applicant	Hologic Inc. 250 Campus Drive Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Bryce Dzialo Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QYV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/27/2021
Decision Date	01/31/2024
Decision	DENG -
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review