DEVICE: Image filing software (04987669100523)

Device Identifier (DI) Information

Image filing software
NAVIS-EX
In Commercial Distribution

NIDEK CO.,LTD.
04987669100523
GS1

1
690635461 *Terms of Use
The NAVIS-EX image filing software is software that acquires data from the following NIDEK fundus photography devices and files it for easy transfer to external systems. NAVIS-EX is equipped with functions for image acquiring, image display, image drawing, image processing, image measurement, panorama image creation, stereo image observation, composite image creation, and Follow-Up. (According to the image, available functions are limited.) Image data can be transferred by network or e-mail. NAVIS-EX can construct a network among multiple terminals and refers to and edits data from the client PC.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Anterior eye segment analyser software An application software program designed for the collection, processing, and display of data resulting from the measurement/evaluation of various properties of the anterior eye segment (i.e., cornea, iris, pupil, anterior chamber and lens) performed with an anterior eye segment analyser. It may be installed in the integrated analyser computer and/or an off-the-shelf computer (e.g., desktop, laptop).
Posterior eye segment analyser software An application software program designed for the collection, processing, and display of data resulting from the measurement/evaluation of various properties of the posterior eye segment performed with an anterior eye segment analyser. It may be installed in the integrated analyser computer and/or an off-the-shelf computer (e.g., desktop, laptop).
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FDA Product Code

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Product Code Product Code Name
NFG Device, Communications, Images, Ophthalmic
NFF Device, Storage, Images, Ophthalmic
MYC Ophthalmoscope,Laser,Scanning
HKI Camera, Ophthalmic, Ac-Powered
HPT Perimeter, Automatic, Ac-Powered
OBO Tomography, Optical Coherence
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

9ddff429-6309-4b7d-af5f-2eb7006bd8d4
April 25, 2018
3
August 26, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Unit of Use DI

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Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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