FDA 510(k) Application Details - K241891

Device Classification Name	More FDA Info for this Device
510(K) Number	K241891
Device Name	ScreenDx
Applicant	Imvaria, Inc 2930 Domingo Ave #1496 Berkeley, CA 94705 US Other 510(k) Applications for this Company
Contact	Joshua Reicher Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QWO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/28/2024
Decision Date	01/10/2025
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