FDA 510(k) Application Details - K180647

Device Classification Name	More FDA Info for this Device
510(K) Number	K180647
Device Name	BriefCase
Applicant	Aidoc Medical, Ltd. Yigal Alon 92 Tel-Aviv 6789138 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	03/12/2018
Decision Date	08/01/2018
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