FDA 510(k) Application Details - K181345

Device Classification Name	System, Image Management, Ophthalmic   More FDA Info for this Device
510(K) Number	K181345
Device Name	System, Image Management, Ophthalmic
Applicant	Nidek Co., Ltd 34-14 Maehama Hiroishi-cho Gamagori 443-0038 JP Other 510(k) Applications for this Company
Contact	Yoneji Mizuno Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	NFJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/2018
Decision Date	07/19/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review