FDA 510(k) Application Details - K180473

Device Classification Name	More FDA Info for this Device
510(K) Number	K180473
Device Name	ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR
Applicant	ECOTRON Co., Ltd Rm 504, Hanshin IT Tower II, 47, Digital-ro 9-gil Geumcheon-gu Seoul 153-712 KR Other 510(k) Applications for this Company
Contact	Sang Bond Lee Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/22/2018
Decision Date	03/23/2018
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