FDA 510(k) Application Details - K221449

Device Classification Name	More FDA Info for this Device
510(K) Number	K221449
Device Name	Genius AI Detection 2.0
Applicant	Hologic, Inc. 250 Campus Drive Marlborough, MA 01730 US Other 510(k) Applications for this Company
Contact	Deborah Thomas Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/18/2022
Decision Date	10/06/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review