FDA 510(k) Application Details - K192383

Device Classification Name	More FDA Info for this Device
510(K) Number	K192383
Device Name	BriefCase
Applicant	Aidoc Medical, Ltd. 3 Aminadav St. Tel-Aviv 6706703 IL Other 510(k) Applications for this Company
Contact	Nimrod Epstein Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/30/2019
Decision Date	12/20/2019
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