FDA 510(k) Application Details - K182177

Device Classification Name	More FDA Info for this Device
510(K) Number	K182177
Device Name	Accipiolx
Applicant	MaxQ-Al Ltd. 76 Yigal Alon Street, 5th Floor Tel Aviv 6706701 IL Other 510(k) Applications for this Company
Contact	Joshua Schulman 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	08/10/2018
Decision Date	10/26/2018
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