FDA 510(k) Application Details - K202013

Device Classification Name	More FDA Info for this Device
510(K) Number	K202013
Device Name	WRDensity by Whiterabbit.ai
Applicant	Whiterabbit.ai Inc. 3930 Freedom Cir. Ste 101 Santa Clara, CA 95054 US Other 510(k) Applications for this Company
Contact	Jason Su Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/21/2020
Decision Date	10/30/2020
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