Image filing software

GUDID 04987669100523

The NAVIS-EX image filing software is software that acquires data from the following NIDEK fundus photography devices and files it for easy transfer t

NIDEK CO.,LTD.

Eye anterior segment analyser software
Primary Device ID04987669100523
NIH Device Record Key9ddff429-6309-4b7d-af5f-2eb7006bd8d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameImage filing software
Version Model NumberNAVIS-EX
Company DUNS690635461
Company NameNIDEK CO.,LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-223-9044
Emailinfo@nidek.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104987669100523 [Primary]

FDA Product Code

NFGDevice, Communications, Images, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2018-09-24
Device Publish Date2016-08-26

Devices Manufactured by NIDEK CO.,LTD.

04987669200018 - A-scan probe2023-07-18 It is used to scan axial length with the ultrasonic measurement function which equipped with the OPTICAL BIOMETER AL-Scan.
04987669200049 - Pachymetry probe (45° fixed type)2023-07-18 It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the OPTICAL BIOMETER AL-Scan.
04987669200070 - A-scan probe2023-07-18 It is used to scan axial length with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000.
04987669200094 - Pachymetry probe2023-07-18 It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000.
04987669200100 - Pachymetry probe (45° fixed type)2023-07-18 It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000.
04987669200117 - A-scan probe2023-07-18 It is used to scan axial length with the ultrasonic measurement function which equipped with the ECHOSCAN US-500.
04987669200780 - IOL-Station2023-07-18 The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Analyzer model OPD-Scan III, Optica
04987669100844 - IOL-Station2023-06-20 The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Analyzer model OPD-Scan III, Optica

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