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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Management, Ophthalmic
510(k) Number K181345
Device Name Image Filing Software NAVIS-EX
Applicant
Nidek Co., Ltd.
34-14 Maehama
Gamagori,  JP 443-0038
Applicant Contact Yoneji Mizuno
Correspondent
Nidek Technologies Srl
Via Dell'Artigianato, 6/A
Albignasego (Padova),  IT 35020
Correspondent Contact Enrico Bisson
Regulation Number892.2050
Classification Product Code
NFJ  
Subsequent Product Codes
HJO   HKI   IYO   NFF   NFG  
NQE   OBO  
Date Received05/21/2018
Decision Date 07/19/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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